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NCT Number: NCT06979141

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

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.

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Key information

Conditions

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

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Asyut, 2091110, Egypt

Location status: Recruiting

Location contact

Mahmoud T Abd Elhafeez, Specialist.Mcs

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: dex

Magnesium sulfate

Drug

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

Other names: MgSO4

Lidocaine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Cough suppression as regard number and severity.

    Time frame: 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 outcomes

  1. Intraoperative heart rate (HR).

    Time frame: 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.

  2. Intraoperative mean arterial blood pressure (MAP).

    Time frame: 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.

  3. Intraoperative arterial oxygen saturation (Spo2).

    Time frame: 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.

  4. Sedation score.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Medhat H Allam, lecturer.MD

CONTACT

[email protected]

1003012989 ext. +020

Osama H Ahmed, Professor.MD

CONTACT

[email protected]

1223460571 ext. +020

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Comparative Study Between Efficacy of Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression During General Anesthetic Emergence

Acronym: MgSO4/DEX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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