Effect of Preoperative Nebulized Magnesium Sulfate on Post-intubation Stress Response in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Difference between preoperative cortisol level and 6minutes after intubation
研究概览
简要总结
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:
- Demographic data collection (age, weight, height, BMI, and ASA).
- Complete clinical examination.
- 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.
详细描述
B. Intraoperatively:
SBP, DBP, HR, and blood glucose level will be measured at the following intervals: Baseline (before induction), after premedication (sedation), after induction, after ETT intubation, 3 min later, 6 min later.
Full monitoring data (Blood pressure every 3 minutes, ECG, Nanogram, and pulse oximeter) will be collected till 6 minutes then every 5 minutes. Random blood sugar will be tested 5 minutes pre-intubation, 3minutes and 5 minutes after intubation and recorded.
After end of nebulization, sedation with 2 mg midazolam and IV fluids (10 ml/kg) were infused to avoid tachycardia of dehydration and fear of surgery. Then, we proceed on general anesthesia through Propofol titration + fentanyl 100 mcg + Cis-atracurium 0.15 mg/kg. Endotracheal intubation with cuffed tube and mechanical ventilation with mild increase in respiratory rate 14-16/min to overcome CO2 peritoneal insufflation.
All patients will receive intraoperatively, nalbuphine 0.1 mg/kg + ketorolac 60 mg + paracetamol IV 1 g. Dexamethasone 4mg + Ondansetron 4mg will receive to all patients for prophylaxis against postoperative nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American society of anesthesiologists (ASA) physical status I-II.
- •Elective fit laparoscopic cholecystectomy
排除标准
- •• 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.
研究组 & 干预措施
Nebulized magnesium sulfate group
Patients will receive nebulized magnesium sulfate in 5 ml (250 mg) over 15 min.
干预措施: Nebulization of magnesium sulfate (Procedure)
control group
Patients will receive nebulized normal saline 5ml, 15 minutes preoperatively
结局指标
主要结局
Difference between preoperative cortisol level and 6minutes after intubation
时间窗: 6 minutes 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
次要结局
- NRS for sore throat postoperatively(24 hours)
- 4 grade scale(24 hours postoperatively)
- Random blood sugar RBS(6 minutes after intubation)
研究者
Ayman Abd El-Khalek Mohammed Glala
Lecturer
Assiut University