## Protocol Section
### Identification Module
**NCT ID:** NCT06432621

**Brief Title:** Role of Sugammadex and Neostigmine for Recovery From Rocuronium

**Official Title:** Sugammadex Versus Neostigmine for Recovery of Respiratory Muscle Strength Measured by Ultrasonography in the Postextubation Period in Laparoscopic Cholecystectomy

#### Organization Study ID Info
**ID:** MD201/2023
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-19
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Ahmed wagih Ezzat deusouky

**Investigator Title:** lecturer of anasthesia,intensive care and pain management

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** evaluation the reversal of neuromuscular blocking by sugammadex versus neostigmine through assessing the residual neuromuscular blocking effect by ultrasound imaging of expiratory muscle strength and diaphragmatic excursion.

**Detailed Description:** All patients will be assessed preoperatively by careful history taking (history of allergy to rocuronium, neostigmine, or sugammadex), full medical history taking , ASA classification and surgical history Premedication with 2mg midazolam. Anesthesia will be induced with propofol 1-2 mg /kg and fentanyl 1-2 mic/kg. After calibration of TOF (train of four) rocuronium 0.6 mg/kg will be administered, and tracheal intubation will be performed in the absence of train-of four (TOF) count. Rocuronium 0.15mg/kg and Sevoflurane will be used for maintenance of anesthesia.

At the end of the surgery, patients in group A will receive sugammadex (2 mg/kg) and patients in group B will receive neostigmine (50 μg/kg, maximum 5 mg) combined with atropine (25 μg/kg, maximum 2.5 mg) after TOF counts at least exceeding 1 and extubation will be performed in the operating room when the patient is fully awake and fulfilled clinical criteria for extubation.

Diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography.

### Conditions Module

**Conditions:**

- Anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients who will receive sugammadex for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.

**Intervention Names:**

- Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation

**Label:** Group S

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** patients who will receive neostigmine for recovery from rocuronium and its effect will be assessed by ultrasound and nerve stimulation.

**Intervention Names:**

- Procedure: using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation

**Label:** Group N

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group N

- Group S

**Description:** patients will be randomly divided into two groups using a computer generated random number chart. Group S will receive sugammadex for reversal of rocuronium, whereas Group N will receive neostigmine for reversal of rocuronium using nerve stimulation and ultrasound to asses recovery of respiratory muscle

**Name:** using of sugammadex and neostigmine for reversal from rocuronium and assessment of response using ultrasound and nerve stimulation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** complete recovery of skeletal muscle assesed by train of four and diaghragmatic excursion by ultrasuond automatically recorded utilizing the TOF monitoring TFIO and diaphragm excursion (DE), reflecting the expiratory and inspiratory muscle strength, respectively, will be measured via ultrasonography (Sonosite M-Turbo) at 3 predefined time points: before induction (baseline levels), TOFR ≥0.9 (postextubation), and after 30 minutes in the PACU.

**Measure:** effect of sugammadex and neostigmine on reversal of rocuronium

**Time Frame:** 4 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with American Society of Anesthesiology (ASA) physical status classification I and II

Exclusion Criteria:

* 1. American Society of Anesthesiology (ASA) physical status classification III-V 2. renal impairment 3. Significant liver disease (Child-Pugh B or C class) 4. History of chronic obstructive pulmonary disease 5. Known or suspected neuromuscular disease. 6. Cardiac arrhythmia or use of antiarrhythmic drugs.

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Faculty of Medicine, Ain Shams University

## Derived Section

### Intervention Browse Module - Ancestors

- 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: D000002800

- Term: Cholinesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000010277

- Term: Parasympathomimetics

- ID: D000001337

- Term: Autonomic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12333

- Name: Neostigmine

- Relevance: HIGH

- As Found: Head and Neck Cancer

- ID: M1666

- Name: Rocuronium

- Relevance: HIGH

- As Found: Etoposide

- ID: M6684

- Name: Neuromuscular Nondepolarizing Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12409

- Name: Neuromuscular Blocking Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6040

- Name: Cholinesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077123

- Term: Rocuronium

- ID: D000009388

- Term: Neostigmine

### Misc Info Module

- Version Holder: 2024-05-31
