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

NCT ID: NCT06979141

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2026-08-01

Brief Summary

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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

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Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine group ( D group )

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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

Control group ( C group )

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Magnesium sulfate

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

Intervention Type DRUG

Lidocaine

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

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Other Intervention Names

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dex MgSO4

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Talaat Abd Elhafeez Ahmed

Specialist. Mcs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud T Abd Elhafeez, Specialist.Mcs

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Medhat H Allam, lecturer.MD

Role: CONTACT

1003012989 ext. +020

Osama H Ahmed, Professor.MD

Role: CONTACT

1223460571 ext. +020

Facility Contacts

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Mahmoud T Abd Elhafeez, Specialist.Mcs

Role: primary

Other Identifiers

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MD/AZ.AST./AIP029/7/240/2/2025

Identifier Type: -

Identifier Source: org_study_id

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