Effect of Magnesium Sulfate Nebulization on Postoperative Sore Throat and Stress Response Induced Tracheal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of post-operative sore throat at 0 hours in both groups
研究概览
简要总结
Magnesium sulfate has many mechanisms of action for attenuating the stress response as inhibition of catecholamine releasing from the adrenal medulla, keeping the plasma concentration of epinephrine at a fixed level, decreasing the circulating norepinephrine level when compared to that of a control group[ and also has a vasodilation effect on systemic and coronary blood vessels by blocking calcium ion in vascular smooth muscle.-Methyl- D-Aspartate (NMDA) antagonism is an amazing recent discovery for magnesium sulphate to play an important role in stress response.
In this study, we will study the effects of nebulized magnesium sulfate on hemodynamics during intubation.
详细描述
Inclusion criteria
- 20-50 years old
- ASA: 1, 2
- Elective fit laparoscopic cholecystectomy Exclusion criteria
- 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 > 40
Study tools:
Following institutional ethical committee approval and written informed consent,a prospective randomized double-blinded study. After written informed consent wil be given, 100 patients, ASA 1 or 2, aged between 20 - 50 years, scheduled for elective surgery with Orotracheal Intubation (OTI) will be assessed for eligibility. Patients will be recruited in the study divided into two equal groups; Patients in Group A: will receive nebulized magnesium sulfate in 3 ml (240 mg) over 15 min, While group B: will receive nebulized normal saline in 3 ml over 15 min, ending 5 min before the induction of anesthesia. 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) wil 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
the participant will not know whither a magnesium sulfate inhalation or distilled water in the vaporizer
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-50 years old
- •ASA: 1, 2
- •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 > 40
结局指标
主要结局
Incidence of post-operative sore throat at 0 hours in both groups
时间窗: at 0 hours in both groups
Incidence of post-operative sore throat 0 h
Incidence of post-operative sore throat at 2 hours in both groups
时间窗: at 2 hours in both groups
Incidence of post-operative sore throat 2 h
Incidence of post-operative sore throat at 24 hours in both groups
时间窗: at 24 hours in both groups
Incidence of post-operative sore throat 24 h
Incidence of post-operative sore throat at 4 hours in both groups
时间窗: at 4 hours in both groups
Incidence of post-operative sore throat 4 h
次要结局
- Improvement in postoperative stress response after (3, 6) minutes including: • Heart rate > 20% baseline • Systolic and mean BP >25% baseline • Random blood sugar increase > 50 mg/dl from baseline((3, 6) minutes)
- Effect on Pain score VAS 2hours after recovery(2hours after recovery)
研究者
Ayman Abd El-Khalek Mohammed Glala
principal investigator
Assiut University