## Protocol Section
### Identification Module
**NCT ID:** NCT00751179

**Brief Title:** Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

**Official Title:** A Multi-center, Randomized, Parallel Group, Comparative, Active Controlled, Safety Assessor Blinded Trial in Adult Subjects Comparing Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Subjects Undergoing Short Surgical Procedures in Out-patient Surgicenters

#### Organization Study ID Info
**ID:** P05700
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**ID:** 19.4.319
### Status Module
#### Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-06-30

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-03-20

**Type:** ESTIMATED

**Results First Submit Date:** 2012-02-23

**Results First Submit QC Date:** 2012-02-23

#### Start Date
**Date:** 2008-11

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2008-09-11
**Type:** ESTIMATED
**Study First Submit Date:** 2008-09-10
**Study First Submit QC Date:** 2008-09-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.

### Conditions Module

**Conditions:**

- Neuromuscular Blockade

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 161

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Rocuronium - Sugammadex 4.0 mg/kg

**Intervention Names:**

- Drug: rocuronium

- Drug: sugammadex

**Label:** Rocuronium - Sugammadex

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Succinylcholine 1.0 mg/kg

**Intervention Names:**

- Drug: succinylcholine

**Label:** Succinylcholine

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Rocuronium - Sugammadex

**Description:** A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block.

**Name:** rocuronium

**Other Names:**

- Zemuron® Injection (rocuronium bromide)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Rocuronium - Sugammadex

**Description:** At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered.

**Name:** sugammadex

**Other Names:**

- sugammadex sodium injection

- SCH 900916

- Org 25969

- Bridion

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Succinylcholine

**Description:** A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.

**Name:** succinylcholine

**Other Names:**

- Quelicin® (succinylcholine chloride injection United States Pharmacopeia [USP])

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine

**Time Frame:** Baseline and 5 minutes post dose

**Description:** Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex

**Time Frame:** Baseline and 5 minutes post dose

#### Secondary Outcomes

**Description:** Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine

**Time Frame:** Baseline and 2 minutes post dose

**Description:** Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex

**Time Frame:** Baseline and 2 minutes post dose

**Description:** Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine

**Time Frame:** Baseline and 10 minutes post dose

**Description:** Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex

**Time Frame:** Baseline and 10 minutes post dose

**Description:** Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine

**Time Frame:** Baseline and 15 minutes post dose

**Description:** Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

**Measure:** Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex

**Time Frame:** Baseline and 15 minutes post dose

**Description:** Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered "pretreatment" events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).

**Measure:** Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups

**Time Frame:** Up to 7 days post dose

**Description:** Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.

**Measure:** Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium

**Time Frame:** Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)

**Description:** Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.

**Measure:** Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine

**Time Frame:** Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female subjects \>=18 years of age;
* ASA Class 1-3;
* Subjects with a Body Mass Index (BMI) of \< 35 kg/m\^2 ;
* Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;
* Subjects scheduled to undergo an elective surgical procedure expected to last 1.5 hours or less (from end of intubation to end of suturing/stapling of skin);
* Subjects who are scheduled to undergo an elective surgical procedures that allows access to the arm for TOF-Watch® SX monitoring;
* Subjects who have given written informed consent.

Exclusion Criteria:

* Subjects known to have ischemic heart disease or a history of myocardial infarction;
* Subjects in whom a difficult intubation is expected because of anatomical malformations;
* Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);
* Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis);
* Subjects who would require the use of pneumatic tourniquet during the surgical procedure;
* Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance \< 30 mL per min);
* Subjects known or suspected to have significant hepatic dysfunction;
* Subjects known or suspected to have a (family) history of malignant hyperthermia;
* Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins or rocuronium or any of its excipients;
* Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants, or other medications used during general anesthesia;
* Subjects for whom a pre-established need for post operative intensive care admission and/or hospital admission is expected;
* Subjects for whom an intra operative IV administration of fluids that contain potassium is expected;
* Female subjects who are pregnant;
* Female subjects who are breast-feeding;
* Subjects who have participated in a previous sugammadex trial;
* Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial (CT) 19.4.319 (P05700) unless pre-approved by the sponsor.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### References Module

#### References

**Citation:** Soto R, Jahr JS, Pavlin J, Sabo D, Philip BK, Egan TD, Rowe E, de Bie J, Woo T. Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial. Am J Ther. 2016 Nov/Dec;23(6):e1654-e1662. doi: 10.1097/MJT.0000000000000206.

**PMID:** 25768376

**Citation:** Sabo D, Jahr J, Pavlin J, Philip B, Shimode N, Rowe E, Woo T, Soto R. The increases in potassium concentrations are greater with succinylcholine than with rocuronium-sugammadex in outpatient surgery: a randomized, multicentre trial. Can J Anaesth. 2014 May;61(5):423-32. doi: 10.1007/s12630-014-0128-7. Epub 2014 Apr 8.

**PMID:** 24710957

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000927

- Term: Anticonvulsants

- ID: D000003473

- Term: Neuromuscular Nondepolarizing Agents

- ID: D000009466

- Term: Neuromuscular Blocking Agents

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000009467

- Term: Neuromuscular Depolarizing Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M5241

- Name: Bromides

- Relevance: HIGH

- As Found: Half

- ID: M1666

- Name: Rocuronium

- Relevance: HIGH

- As Found: Sub-

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: M16177

- Name: Succinylcholine

- Relevance: HIGH

- As Found: Alpelisib

- ID: M4246

- Name: Anticonvulsants

- Relevance: LOW

- As Found: Unknown

- ID: M6684

- Name: Neuromuscular Nondepolarizing Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12409

- Name: Neuromuscular Blocking Agents

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001965

- Term: Bromides

- ID: D000077123

- Term: Rocuronium

- ID: D000013390

- Term: Succinylcholine

### Misc Info Module

#### Removed Countries

- Country: Canada

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Includes only AEs post sugammadex or succinylcholine. AE reporting interval included entire intubation/surgical period for succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).

#### Event Groups

**Group ID:** EG000

**Title:** Rocuronium - Sugammadex

**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.

**ID:** EG000

**Other Num Affected:** 57

**Other Num at Risk:** 66

**Serious Number Affected:** 1

**Serious Number At Risk:** 66

**Title:** Rocuronium - Sugammadex

**Group ID:** EG001

**Title:** Succinylcholine

**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.

**ID:** EG001

**Other Num Affected:** 67

**Other Num at Risk:** 80

**Serious Number Affected:** 3

**Serious Number At Risk:** 80

**Title:** Succinylcholine

**Frequency Threshold:** 5

#### Other Events

**Term:** Abdominal pain

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Nausea

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Vomiting

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

**Term:** Incision site pain

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (12.1)

**Term:** Procedural hypotension

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (12.1)

**Term:** Procedural nausea

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (12.1)

**Term:** Procedural pain

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (12.1)

**Term:** Myalgia

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (12.1)

#### Serious Events

**Term:** Rectal hemorrhage

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (12.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Procedural nausea

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (12.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 66

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 80

**Term:** Medical observation

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Term:** Oxygen saturation decreased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (12.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 80

**Num Events:** 1

**Time Frame:** Up to 7 days post dose

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 66

**Group ID:** BG001

**Value:** 80

**Group ID:** BG002

**Value:** 146

**Units:** Participants

### Group

**ID:** BG000

**Title:** Rocuronium - Sugammadex

**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.

### Group

**ID:** BG001

**Title:** Succinylcholine

**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13

**Value:** 40

#### Measurement

**Group ID:** BG001

**Spread:** 14

**Value:** 45

#### Measurement

**Group ID:** BG002

**Spread:** 14

**Value:** 43

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 48

#### Measurement

**Group ID:** BG001

**Value:** 53

#### Measurement

**Group ID:** BG002

**Value:** 101

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 45

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** Includes only participants who were randomized and treated with sugammadex or succinylcholine
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Description:** Includes only participants who were randomized and treated with sugammadex or succinylcholine
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** If a proposed publication contains reference to an invention owned by the Sponsor or to which the Sponsor otherwise has rights, the Sponsor may request a reasonable suspension of the publication in order to be able to file a patent application protecting such invention.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The potassium change from baseline interval included most/all of the intubation/surgical period for the sug but not the suc or roc analysis. AE reporting interval included the entire intubation/surgery period for the suc but not the roc-sug group.
### Point of Contact
**Email:** ClinicalTrialsDisclosure@merck.com
**Organization:** Merck Sharp & Dohme Corp
**Title:** Senior Vice President, Global Clinical Development
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Significance level was set at 0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Significance level was set at 0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** False
### Outcome Measure 3
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Significance level was set at 0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** False
### Outcome Measure 5
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Significance level was set at 0.05.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** False
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.32
- **Upper Limit:** 
- **Value:** -0.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.34
- **Upper Limit:** 
- **Value:** 0.30
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.30
- **Upper Limit:** 
- **Value:** -0.09
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.36
- **Upper Limit:** 
- **Value:** 0.19
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.39
- **Upper Limit:** 
- **Value:** -0.02
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.27
- **Upper Limit:** 
- **Value:** -0.01
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.41
- **Upper Limit:** 
- **Value:** 0.32
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.38
- **Upper Limit:** 
- **Value:** 0.07
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.26
- **Upper Limit:** 
- **Value:** 0.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** 0.33
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.39
- **Upper Limit:** 
- **Value:** 0.07
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.42
- **Upper Limit:** 
- **Value:** 0.02
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 60
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.59
- **Spread:** 
- **Upper Limit:** 2.03
- **Value:** 1.79
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 10.06
- **Spread:** 
- **Upper Limit:** 11.52
- **Value:** 10.76
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 5 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine
**Type:** PRIMARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
##### Group
**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
**ID:** OG001
**Title:** Succinylcholine
#### Outcome Measure 2
**Description:** Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 2 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
##### Group
**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
**ID:** OG001
**Title:** Succinylcholine
#### Outcome Measure 3
**Description:** Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 2 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
#### Outcome Measure 4
**Description:** Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 10 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
##### Group
**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
**ID:** OG001
**Title:** Succinylcholine
#### Outcome Measure 5
**Description:** Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 10 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
#### Outcome Measure 6
**Description:** Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 15 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
##### Group
**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
**ID:** OG001
**Title:** Succinylcholine
#### Outcome Measure 7
**Description:** Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 15 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
#### Outcome Measure 8
**Description:** Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 5 minutes post dose
**Title:** Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex
**Type:** PRIMARY
**Unit of Measure:** mmol/L
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
#### Outcome Measure 9
**Description:** Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered "pretreatment" events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure).
**Parameter Type:** NUMBER
**Population Description:** Participants who received sugammadex or succinylcholine.
**Reporting Status:** POSTED
**Time Frame:** Up to 7 days post dose
**Title:** Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
##### Group
**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
**ID:** OG001
**Title:** Succinylcholine
#### Outcome Measure 10
**Description:** Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.
**Reporting Status:** POSTED
**Time Frame:** Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)
**Title:** Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium
**Type:** SECONDARY
**Unit of Measure:** Minutes
##### Group
**Description:** An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
**ID:** OG000
**Title:** Rocuronium - Sugammadex
#### Outcome Measure 11
**Description:** Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.
**Reporting Status:** POSTED
**Time Frame:** Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)
**Title:** Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine
**Type:** SECONDARY
**Unit of Measure:** Minutes
##### Group
**Description:** An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
**ID:** OG000
**Title:** Succinylcholine
### Participant Flow Module
#### Group
**Description:** An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade.
**ID:** FG000
**Title:** Rocuronium - Sugammadex
#### Group
**Description:** An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
**ID:** FG001
**Title:** Succinylcholine
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 76
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 85
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 62
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 70
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 15
**Has Results:** True