Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia

NCT06979141 | Recruiting Phase 3 DMC

• 1 other identifier: MD/AZ.AST./AIP029/7/240/2/2025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective randomized controlled double-blinded study is to compare the efficacy of dexmedetomidine, MgSO4 and lidocaine for cough suppression during general anesthetic emergence as regard number and severity.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• Cough suppression as regard number and severity.

  Coughing severity will be classified using the 3 point scale described by Minogue et al.: 1 = mild, single cough, 2 = moderate (lasting for \<5 seconds) cough, and severe (lasting for \>5 seconds) cough.

  at 0 and 10,20,30,40 minutes after endotracheal extubation.

Secondary Outcomes (4)

• Intraoperative heart rate (HR).

  at 15-minutes interval.

• Intraoperative mean arterial blood pressure (MAP).

  at 15-minutes interval.

• Intraoperative arterial oxygen saturation (Spo2).

  at 15-minutes interval.

• Sedation score.

  at 0,10,20,30, and 40 minutes after tracheal extubation.

Study Arms (4)

Dexmedetomidine group ( D group )

ACTIVE COMPARATOR

Patients will receive 0.5 μg/kg dexmedetomidine in 10 ml normal saline 10 min before the end of surgery.

Drug: Dexmedetomidine

Magnesium sulfate group ( M group )

ACTIVE COMPARATOR

Patients will receive 30 mg/kg IV magnesium sulfate 50% in 10 ml normal saline 10 min before the end of surgery.

Drug: Magnesium sulfate

Lidocaine group ( L group )

ACTIVE COMPARATOR

Patients will receive lidocaine 1.5 mg/kg lidocaine in 10 ml normal saline 10 min before the end of surgery.

Drug: Lidocaine

Control group ( C group )

PLACEBO COMPARATOR

Patients will receive 10 ml normal saline 10 min before the end of surgery.

Drug: normal saline

Interventions

Dexmedetomidine DRUG

Patients will receive 0.5 μg/kg dexmedetomidine in 10ml normal saline 10 min before the end of surgery.

Also known as: dex

Dexmedetomidine group ( D group )

Magnesium sulfate DRUG

Patients will receive 30 mg/kg IV magnesium sulfate 50% 10 min before the end of surgery.

Also known as: MgSO4

Magnesium sulfate group ( M group )

Lidocaine DRUG

Patients will receive lidocaine 1.5 mg/kg lidocaine 10 min before the end of surgery.

Lidocaine group ( L group )

normal saline DRUG

Patients will receive 10 ml normal saline 10 min before the end of surgery.

Control group ( C group )

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 21-60 years.
• Both genders.
• Body mass index \< 30 kg/ m2
• American Society of Anesthesiology (ASA) physical status I-II.
• Mallampati score class I or II.
• Patients undergoing surgery under general anesthesia.

You may not qualify if:

• Known allergy to study drugs.
• History of psychiatric illness.
• Patients with major organ diseases.
• Pre-existing neurological deficits.
• Body mass index \>30 kg/m2.
• Active airway infection or history of tracheal and laryngeal surgery.
• Lower esophageal sphincter incompetence (and reflux).
• Increased intracranial and intraocular pressure.
• Use of cough-inducing medications
• Pregnant, and lactating women.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Medicine, Al-Azhar university Assiut, Egypt.

Asyut, 2091110, Egypt

RECRUITING

MeSH Terms

Conditions

Cough

Interventions

Dexmedetomidine; Magnesium Sulfate; Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mahmoud T Abd Elhafeez, Specialist.Mcs

  mahmoud.talaat750@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medhat H Allam, lecturer.MD

CONTACT

1003012989; Medhathelaly@gmail.com

Osama H Ahmed, Professor.MD

CONTACT

1223460571; DOCTOR_OSAMA_HELAL@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist. Mcs

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)