Effect of MgSo4 Infusion on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Surgery.A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pao2/FIO2
研究概览
简要总结
The purpose of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery
详细描述
Background and objectives: morbidly obese patients are characterized by a high prevalence of restrictive lung disease. Respiratory mechanics are significantly altered in obesity. These changes are exacerbated with general anesthesia .Obesity also results in reduced lung and chest wall compliance ,increased lung resistance ,reduced oxygenation.MgSo4 is promising in managing several respiratory disorders.it cause smooth muscle relaxation and reduce airflow obstruction.
The objective of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery.
the following will be recorded :intraoperative oxygenation,lung mechanics,MAP,HR,EtCO2,plateau and peak airway pressure,sedation score,serum mgso4 level,change in P/F ratio and dynamic lung compliance,respiratory rate postoperative
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age between 21-60 years.
- •BMI more than 40kg/m2
- •Patients with restrictive lung disease(FVC>70%)
- •American society of Anesthesiologists(ASA) physical status II
- •No previous abdominal surgery
- •Scheduled for laparoscopic bariatric surgery not exceeding 3 hours.
排除标准
- •Patient refusal to participate in the study
- •ASA physical status more than II
- •patients with heart failure
- •Kidney disease
- •Patients on antiarrhythmic drugs
- •Patients taking beta or calcium channel blockers
- •Allergy to study drugs
- •Patients with combined restrictive-obstructive lung disease
研究组 & 干预措施
M group (Mg sulphate )
patients will receive 30mg/kg LBW of 10%mgso4 in 100 ml normal saline intravenously over 30 minutes as a loading dose ,followed by 10 mg /kg LBW for 90 minutes
干预措施: mg sulphate (Drug)
结局指标
主要结局
Pao2/FIO2
时间窗: 5 minutes after intubation to 90 minutes after starting drug infusion
arterial oxygenation during surgery determined by Pao2/FIO2
Pao2
时间窗: 5 minutes after intubation to 90 minutes after starting drug infusion
arterial oxygenation during surgery determined by Pao2
次要结局
- mg sulphate level(One hour postoperatively)
- Dynamic lung compliance(5 minutes after intubation to 90 minutes after starting drug infusion)
- Static lung compliance(5 minutes after intubation to 90 minutes after starting drug infusion)
- dead space(5 minutes after intubation to 90 minutes after starting drug infusion)
研究者
Marwa Mostafa Mohamed Ali Mowafi
Lecturer of anesthesia ,principal Investigator
Ain Shams University