Effect of Nebulized Magnesium Sulfate on Post-intubation Stress Response in Patients Undergoing Laparoscopic Cholecystectomy
NCT07123714 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2025-08-14
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.
Conditions
- Sore Throat
Interventions
- PROCEDURE
-
Nebulization of magnesium sulfate
patient will be nebulized with 5 mg magnesium sulfate (5 ml) 15 minutes before induction of anesthesia
Sponsors & Collaborators
-
Assiut University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-20
- Primary Completion
- 2025-11-01
- Completion
- 2025-11-10
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