Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- visual analogue score
研究概览
简要总结
Dexmedetomidine (Dex) activates the α2 adrenergic receptor that is present within the locus coeruleus, leading to anxiolysis, hypnosis, analgesia, and sedation.
We conducted our research to compare the effects of fentanyl and DEX on the postoperative analgesic profile and complications in morbidly obese patients after sleeve gastrectomy.
详细描述
The participants were assigned to two groups of equal size (32 patients in each group) by the use of computer-generated numbers and sealed opaque envelopes. The participants allocated to the DEX group, also known as Group D, received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal. The patients assigned to the fentanyl group (referred to as Group F) were administered fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.
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)
盲法说明
double
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
- •body mass index (BMI) of 35 kg/m2 or more.
- •American Society of Anesthesiology (ASA) physical status of II-III.
- •all participants would have a laparoscopic sleeve gastrectomy (LSG).
排除标准
- •allergy to α2 -adrenergic agonist.
- •kidney, liver, neuromuscular disorders, and cardiac disease.
- •or patients on opioid medications.
研究组 & 干预措施
Dexmedetomidine group
Group D, received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal
干预措施: Dexmedetomidine (Drug)
Fentanyl group
Group F were administered fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.
干预措施: Fentanyl (Drug)
结局指标
主要结局
visual analogue score
时间窗: from arrival to PACU until 12 hours after surgery
visual analogue pain score (VAS) from 0-10 (0: no pain, 10: the worst pain). It was assessed in post anesthesia care unit ( PACU) and every 2 hours for 12 hours postoperatively
次要结局
- incidence of nausea and vomiting(2 hours after surgery)
- The time of the first analgesic request(first postoperative day)
- the total opioid dose consumed during the first 12 hours postoperatively(12 hours after surgery)
研究者
Doha Mohammed Bakr
Lecturer of anesthessiology, surgical intensive care and pain medicine
Helwan University