Clinical Trial

Effect of Nebulized Magnesium Sulfate on Post-intubation Stress Response in Patients Undergoing Laparoscopic Cholecystectomy

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Record status
This record was last updated August 14, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This randomized controlled double blinded study will be carried out on 140 patients underwent elective fit laparoscopic cholecystectomy at El-Rajhi Assiut University Hospital. Inclusion criteria: * 20-50 years old. * Both sexes. * American society of anesthesiologists (ASA) physical status I-II. * Elective fit laparoscopic cholecystectomy Exclusion criteria: * Patient refusal. * Patients with history of hypersensitivity to magnesium sulfate. * Patients with coronary ischemic disease, atrioventricular block of any degree, known cardiac arrhythmias, heart failure on beta blockers or calcium channel blockers expected difficult intubation (Mallampati 4). * Body mass index (BMI) \> 40 kg/m2. An online randomization program (http://www.randomizer.org) will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: * Group A: (N=70) Patients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min. * Group B: (N=70) Patients received nebulized normal saline in 5 ml over 15 min, ending 5 min before the induction of anesthesia. A. Preoperative assessment: All patients will be subjected to the followings: 1. Demographic data collection (age, weight, height, BMI, and ASA). 2. Complete clinical examination. 3. Routine Laboratory investigations: * Random blood sugar. * Blood sample withdrawal for cortisol level at baseline 2ml intravenously. The sample will be sent to be centrifugated within 30 minutes and the serum will be separated and stored in -20°C till time of cortisol level by ELIZA technique.
Trial Details
NCT Number NCT07123714
Lead Sponsor Assiut University
Conditions Sore Throat
Enrollment 140 participants
Start Date 2025-08-20
Primary Completion 2025-11-01 (estimated)
Study Completion 2025-11-10 (estimated)
Updated on ClinicalTrials.gov 2025-08-14