About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
American society of anesthesiologists (ASA) physical status I-II.
Elective fit laparoscopic cholecystectomy
Disqualifiers
• Patient refusal.
Patients with history of hypersensitivity to magnesium sulphate.
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.
Trial design
Parallel
Treatments tested in this trial
Nebulization of magnesium sulfate
Procedure/Surgerypatient will be nebulized with 5 mg magnesium sulfate (5 ml) 15 minutes before induction of anesthesia
Treatment groups
Trial outcomes
Primary outcomes
Difference between preoperative cortisol level and 6minutes after intubation
cortisol level will be measured preoperatively and 6 minutes after intubation then calculation of the difference between them then comparison between both groups
Secondary outcomes
NRS for sore throat postoperatively
Pain will be assessed by numeric rating scale NRS asking the patient about his degree of pain graded from 0 to 10 in which 0 refers to no pain at all and 10 refers to the worst pain experienced in life
4 grade scale
examination of the degree of laryngeal dysfunction due to sore throat into 4 grades: grade 1 refers to no pain, 2 refers to pain during swallowing, 3 =continuous pain and increases with swallowing and 4 refers to severe pain that hinders eating and necessitates urgent treatment.
Random blood sugar RBS
RBS refers to stress and known to increase with stress
Locations
Sponsors and contacts
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