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

Phase 3

Not yet recruiting

• Conditions: Cough
• Interventions: Drug: Dexmedetomidine; Drug: Magnesium sulfate; Drug: Lidocaine; Drug: normal saline

• Registration Number: NCT06979141
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group ( D group )	Dexmedetomidine	Patients will receive 0.5 μg/kg dexmedetomidine in 10 ml normal saline 10 min before the end of surgery.
Magnesium sulfate group ( M group )	Magnesium sulfate	Patients will receive 30 mg/kg IV magnesium sulfate 50% in 10 ml normal saline 10 min before the end of surgery.
Lidocaine group ( L group )	Lidocaine	Patients will receive lidocaine 1.5 mg/kg lidocaine in 10 ml normal saline 10 min before the end of surgery.
Control group ( C group )	normal saline	Patients will receive 10 ml normal saline 10 min before the end of surgery.

Primary Outcome Measures

Name	Time	Method
Cough suppression as regard number and severity.	at 0 and 10,20,30,40 minutes after endotracheal extubation.	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative heart rate (HR).	at 15-minutes interval.	Changes in Intraoperative heart rate. change in heart rate per minute (HR/minute) will be all measured from the patient's arrival at the operating room to the end of surgery.
Intraoperative mean arterial blood pressure (MAP).	at 15-minutes interval.	Changes in Intraoperative mean arterial blood pressure (MAP). change in mean arterial blood pressure (MAP) in mmHg will be all measured from the patient's arrival at the operating room to the end of surgery.
Intraoperative arterial oxygen saturation (Spo2).	at 15-minutes interval.	Changes in Intraoperative arterial oxygen saturation (Spo2%). change in arterial oxygen saturation (Spo2%). be all measured from the patient's arrival at the operating room to the end of surgery.
Sedation score.	at 0,10,20,30, and 40 minutes after tracheal extubation.	Sedation score will be recorded using the Ramsay sedation score (Ramsay et al., 1974).