NCT04144153已完成4 期
Opioid Free Total Intravenous Anesthesia Within an Enhanced Recovery After Surgery Pathway for Bariatric Surgery: A Randomized Controlled Clinical Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Quality of Recovery
研究概览
简要总结
The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in 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
- Other
- 盲法
- Double (Participant, 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
- 否
入选标准
- •ASA I-III
- •Non-pregnant
- •Undergoing laparoscopic bariatric surgery for weight loss.
排除标准
- •Unable to obtain informed consent or consent withdrawn.
- •Patients who are pregnant or nursing.
- •Alcohol or narcotic misuse or dependence in the last 2 years.
- •Preoperative daily opioid use for one year for pain management.
- •Egg or soy product allergy
- •Active liver disease
- •Patients with left ventricular assist devices
- •Abnormal renal function
- •Any contraindication to any opioid or non-opioid pain analgesics
- •Any physical, mental or medical condition that in the opinion of the investigator, makes study participation inadvisable.
结局指标
主要结局
Quality of Recovery
时间窗: Up to two postoperative weeks
Quality of Recovery (QoR-15), a patient-reported outcome questionnaire that assesses the quality of functional recovery after surgery and anesthesia with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
次要结局
- Opioid Consumption(Up to postoperative day one)
- Pain Intensities(Up to postoperative day one)
- Time to Aldrete Score of 9(Up to postoperative day one)
研究者
研究点 (2)
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