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RecruitingNCT06979141MgSO4/DEXUpdated Jun 11, 2025

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

A Phase 3 interventional study of Dexmedetomidine and Magnesium sulfate in Cough, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Al-Azhar University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cough

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03

In context

Cough

427 studies on the registry are indexed under Cough; 67 are open to participants now.

This study's planned enrollment of 300 is above the median of 80 across 319 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 21-60 years.
  • Both genders.
  • \< 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

Exclusion Criteria:

  • Known allergy to study drugs.
  • History of psychiatric illness.
  • Patients with major organ diseases.
  • Pre-existing neurological deficits.
  • >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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Dexmedetomidine group ( D group )

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

    Drug: Dexmedetomidine

  • Active comparator
    Magnesium sulfate group ( M group )

    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

  • Active comparator
    Lidocaine group ( L group )

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

    Drug: Lidocaine

  • Placebo comparator
    Control group ( C group )

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

    Drug: normal saline

Interventions

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

    Also known as: dex

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

    Also known as: MgSO4

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

  • Drugnormal saline

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

06

What researchers measure

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.

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

Secondary outcomes

  1. Intraoperative heart rate (HR).

    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.

    Time frame: at 15-minutes interval.

  2. Intraoperative mean arterial blood pressure (MAP).

    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.

    Time frame: at 15-minutes interval.

  3. Intraoperative arterial oxygen saturation (Spo2).

    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.

    Time frame: at 15-minutes interval.

  4. Sedation score.

    Sedation score will be recorded using the Ramsay sedation score (Ramsay et al., 1974).

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06979141
Responsible party
Mahmoud Talaat Abd Elhafeez Ahmed (Specialist. Mcs, Al-Azhar University) — Principal investigator
First posted
May 18, 2025
Start date
Jun 2, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jun 11, 2025

Study contacts

Medhat H Allam, lecturer.MD
Contact
Medhathelaly@gmail.com
1003012989 ext. +020
Osama H Ahmed, Professor.MD
Contact
DOCTOR_OSAMA_HELAL@hotmail.com
1223460571 ext. +020
Mahmoud T Abd Elhafeez, Specialist.Mcs
principal investigator · mahmoud.talaat750@gmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Dexmedetomidine · Magnesium Sulfate · Lidocaine

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