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

ConditionCough
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21-60
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 21-60 years.

Both genders.

Body mass index < 30 kg/ m2

American Society of Anesthesiology (ASA) physical status I-II.

Disqualifiers

Known allergy to study drugs.

History of psychiatric illness.

Patients with major organ diseases.

Pre-existing neurological deficits.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

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

  • Magnesium sulfate

    Drug

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

  • 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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Dexmedetomidine group ( D group )Active comparator 1 intervention
Group B: Magnesium sulfate group ( M group )Active comparator 1 intervention
Group C: Lidocaine group ( L group )Active comparator 1 intervention
Group D: Control group ( C group )Placebo comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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