Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Incidence of postoperative diaphragmatic dysfunction
研究概览
简要总结
Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery
详细描述
Bariatric surgery is associated with several postoperative consequences, including challenging pain control, respiratory complications, and diaphragmatic dysfunction. Postoperative diaphragmatic dysfunction is defined as a diaphragmatic excursion of less than 10 mm. There is substantial evidence that diaphragmatic ultrasound provides a reliable and accurate assessment of diaphragmatic function in both intensive care unit and perioperative settings.
The present randomized controlled trial aims to evaluate the influence of transcutaneous electrical nerve stimulation on postoperative diaphragmatic dysfunction in morbidly obese patients undergoing bariatric surgery.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index > 40 kg/m2
排除标准
- •Limited diaphragmatic ultrasound views
- •Patient with pulmonary diseases (COPD, bronchial asthma, and interstitial fibrosis)
- •Patient refusal
研究组 & 干预措施
Control
Electrodes will be placed identically, but no current will be delivered (sham TENS)
干预措施: Sham TENS (Device)
TENS
Three times daily for the first postoperative day, each session will last 30 minutes
干预措施: Transcutaneous nerve stimulator (Device)
结局指标
主要结局
Incidence of postoperative diaphragmatic dysfunction
时间窗: 2 hours after surgery
Diaphragmatic excursion \< 10 mm 2 hours after surgery
次要结局
- Forced vital capacity (liters)(Before and at 2 and 24 hours postoperatively)
- Numeric rating scale(Within 24 hours after surgery)
- Nalbuphine consumption(24 hours after surgery)
- Forced expiratory volume in one second (Liter)(Before and at 2 and 24 hours)
- Peak expiratory flow rate (Liter/ second)(Baseline, 2, and 24 hours after surgery)
研究者
Mina Adolf Helmy
Assistant Professor of Anesthesiology
Cairo University