Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
研究概览
简要总结
The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.
详细描述
effect of Dexmedetomidine bolus on postoperative morphine requirements
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Body Mass Index > 40 kg/m2 or BMI > 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea
- •American Society of Anesthesiologists class I or II
- •Undergoing laparoscopic sleeve gastrectomy bariatric surgery
排除标准
- •Allergy to morphine or its derivatives
- •Allergy to α-2 adrenergic agonists
- •weight over 180 kg
- •history of uncontrolled hypertension
- •heart block greater than first degree
- •prolonged QT interval
- •clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal diseases
- •received an opioid analgesic medication within a 24 h period prior to surgery
- •history of alcohol, drug abuse or chronic opioid intake
- •history of psychiatric disorder
- •pregnant or breastfeeding.
研究组 & 干预措施
Dexmedetomidine
prior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes
干预措施: Dexmedetomidine (Drug)
Morphine
prior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes
干预措施: Morphine (Drug)
结局指标
主要结局
Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
时间窗: At discharge from the PACU
次要结局
- Time to first morphine requirement in PACU(in the PACU)
- Numeric Rating Scale (NRS) for Pain(in the PACU and at 24 hours)
- NRS for nausea(in the PACU)
- incidence of pruritus(in the PACU)
- incidence of vomiting or retching(in the PACU)
- incidence of respiratory complications(in the PACU)
- time to discharge readiness in PACU(in the PACU)
- total morphine consumption at 24 hours(at 24 hours)
- Quality of Recovery (QoR-40) score at 24 hours(at 24 hours)
- overall satisfaction at one month(one month after surgery)