A comparative study of preoperative Magnesium sulphate nebulization versus intravenous infusion of Magnesium sulphate in controlling post- intubation hemodynamic and stress response in adult patients undergoing elective surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Changes in Hemodynamic parameters following laryngoscopy and intubation in terms of:
研究概览
简要总结
It is a comparative study of preoperative magnesium sulphate nebulization versus intravenous infusion of magnesium sulphate in controlling post- intubation hemodynamic and stress response in adult patients undergoing elective surgeries.
A total number of 130 patients between the age 18 to 65, undergoing elective surgeries will be assigned into 2 groups, group I and group N by Block randomization with sealed envelope system. There will be 65 patients in each group.
Group I will receive intravenous magnesium sulphate and group N will receive magnesium sulphate nebulization.
Primary objective will be to compare the changes in hemodynamic parameters between both groups in terms of Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure, at different time intervals following laryngoscopy and intubation: Baseline (T0), Post intervention/pre-induction(T1), Just before laryngoscopy(T2), 1 min.post-intubation(T3), 3 min.post-intubation(T4), 5 min.post-intubation(T5), 10 min.post-intubation(T6)
Secondary objectives will be to compare : 1)Serum Cortisol level: Baseline and Post intubation (15 min) 2)Serum magnesium level:Baseline and Post intubation (15 min), between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female between the age of 18 to 65 will be included.
排除标准
- •History of hypersensitivity to magnesium sulphate.
- •Anticipated difficult airway.
- •Patients on steroid therapy.
- •Patients on psychiatric medication.
结局指标
主要结局
Changes in Hemodynamic parameters following laryngoscopy and intubation in terms of:
时间窗: At different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
1)Heart rate
时间窗: At different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
2) Systolic blood pressure
时间窗: At different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
3)Diastolic blood pressure
时间窗: At different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
4)Mean arterial pressure
时间窗: At different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
次要结局
- 1)Serum Cortisol level(2)Serum magnesium level)