## Protocol Section
### Identification Module
**NCT ID:** NCT06427707

**Brief Title:** The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries.

**Official Title:** The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions as An Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** FMASU R84/2024
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Rania Maher Hussien, MD

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.

**Detailed Description:** In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries

### Conditions Module

**Conditions:**

- Intraoperative Bleeding

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality in patients undergoing nasal surgeries.

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** intravenous infusion of propofol, lidocaine and magnesium sulfate.

**Intervention Names:**

- Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate

**Label:** Group PLM (propofol-lidocaine-magnesium)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** intravenous infusion of Ketamine, lidocaine and magnesium sulfate

**Intervention Names:**

- Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate

**Label:** Group KLM (ketamine-lidocaine-magnesium)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate

**Intervention Names:**

- Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate

**Label:** Group DLM (Dexmeditomidine-lidocaine-magnesium)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group PLM (propofol-lidocaine-magnesium)

**Description:** intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. the effect of either Propofol injection, or ketamine injection or dexmeditomidine injection on intraoperative bleeding

**Name:** Intravenous Infusion of propofol, lidocaine, Magnesium sulfate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group KLM (ketamine-lidocaine-magnesium)

**Description:** Patients will receive intravenous infusion of Ketamine 0.1-0.2 mg.kg-1.h-1 (intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. dose of 1 mg.kg-1), lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1.

**Name:** Intravenous infusion of ketamine, lidocaine, Magnesium sulfate

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Group DLM (Dexmeditomidine-lidocaine-magnesium)

**Description:** Dexmeditomidine (Precedex® 200 mcg.2ml-1) with a rate of 0.2-0.6 mcg.Kg-1.h-1. lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1

**Name:** Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate

**Other Names:**

- Precedex

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Degree of surgical field bleeding

**Measure:** surgical field using the average category scale (ACS).

**Time Frame:** During the operation

#### Secondary Outcomes

**Description:** Degree of sedation using Ramsy sedation score

**Measure:** sedation using Ramsy sedation score

**Time Frame:** First hour postoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I-II,
* scheduled for elective nasal surgery

Exclusion Criteria:

* Patients with uncontrolled hypertension.
* Patients with cardiac disease.
* Patients with renal, hepatic or cerebral insufficiency.
* Patients with coagulopathy or receiving drugs influencing blood coagulation.
* Anaemia, haemoglobinopathies or polycythemia.
* Pregnancy.
* Patients with known sensitivity to any of the study drug.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drrania_maamon@med.asu.edu.eg

**Name:** RANIA M Hussien, MD

**Phone:** 01000544520

**Phone Ext:** 202

**Role:** CONTACT

**Contact 2:**

**Email:** REC-FMASU@med.asu.edu.eg

**Name:** Fathy Tash, MD

**Phone:** 26857539

**Phone Ext:** 202

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** drrania_maamon@med.asu.edu.eg

- **Name:** Rania M Hussien, MD

- **Phone:** 026213948

- **Phone Ext:** 202

- **Role:** CONTACT

***Contact 2:***

- **Email:** hala_elozairy@med.asu.edu.eg

- **Name:** Hala S El Ozairy, MD

- **Phone:** 01001191199

- **Phone Ext:** 202

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Ain Shams University

**Zip:** 69711

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006470

- Term: Hemorrhage

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007431

- Term: Intraoperative Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M18560

- Name: Blood Loss, Surgical

- Relevance: HIGH

- As Found: Intraoperative Bleeding

- ID: M10465

- Name: Intraoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016063

- Term: Blood Loss, Surgical

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000061567

- Term: Voltage-Gated Sodium Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000778

- Term: Anesthetics, Dissociative

- ID: D000018691

- Term: Excitatory Amino Acid Antagonists

- ID: D000018683

- Term: Excitatory Amino Acid Agents

- ID: D000000927

- Term: Anticonvulsants

- ID: D000002121

- Term: Calcium Channel Blockers

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000015149

- Term: Tocolytic Agents

- ID: D000012102

- Term: Reproductive Control Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M10674

- Name: Ketamine

- Relevance: HIGH

- As Found: Provided

- ID: M18307

- Name: Propofol

- Relevance: HIGH

- As Found: Symptoms

- ID: M11270

- Name: Magnesium Sulfate

- Relevance: HIGH

- As Found: Aerobic exercise

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M4108

- Name: Anesthetics, Dissociative

- Relevance: LOW

- As Found: Unknown

- ID: M20771

- Name: Excitatory Amino Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M4246

- Name: Anticonvulsants

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5384

- Name: Calcium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M17869

- Name: Tocolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008012

- Term: Lidocaine

- ID: D000008278

- Term: Magnesium Sulfate

- ID: D000020927

- Term: Dexmedetomidine

- ID: D000007649

- Term: Ketamine

- ID: D000015742

- Term: Propofol

### Misc Info Module

- Version Holder: 2024-05-31
