Efficacy and Safety of Dexmedetomidine Combined With Desflurane in Laparoscopic Colectomy: A Randomized Double-Blind Controlled Clinical Trial (DEXDES Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Average Desflurane consumption per hour (mL/h) during surgery.
研究概览
简要总结
This randomized double-blind controlled clinical trial aims to evaluate the efficacy and safety of combining Dexmedetomidine with Desflurane in patients undergoing elective laparoscopic colectomy. The study will assess whether the combination can reduce Desflurane consumption, improve intraoperative hemodynamic stability, and enhance postoperative recovery compared to Desflurane alone.
详细描述
Dexmedetomidine, a selective alpha-2 adrenergic agonist, has sedative and analgesic properties without significant respiratory depression. Desflurane, a volatile anesthetic with low blood-gas solubility, allows rapid induction and emergence. Combining these two agents may provide anesthetic-sparing effects and promote faster postoperative recovery under ERAS protocols. This study will enroll 40 adult patients undergoing elective laparoscopic colectomy at Tam Anh General Hospital, Vietnam. Participants will be randomized into two groups: Dexmedetomidine + Desflurane versus Desflurane alone. The primary outcome is average Desflurane consumption per hour, with secondary outcomes including hemodynamic parameters, Fentanyl use, emergence quality, and incidence of postoperative nausea and vomiting.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •ASA Physical Status I-II
- •Elective laparoscopic colectomy
- •Written informed consent provided
排除标准
- •Severe cardiac, hepatic, or renal disease
- •COPD or bronchial asthma
- •Chronic opioid or psychotropic medication use
- •Atrioventricular block (grade II-III), sick sinus syndrome
- •Significant intraoperative bleeding or hemodynamic instability
研究组 & 干预措施
Intervention Group
Arm 1 - Dexmedetomidine + Desflurane (Intervention Group):
Dexmedetomidine bolus 1 µg/kg IV over 15 minutes before induction, followed by continuous infusion 0.5 µg/kg/h during surgery.
Desflurane administered at 1 MAC with EtControl mode.
干预措施: Dexmedetomidine + Desflurane (Drug)
Control Group
Arm 2 - Desflurane + Normal Saline (Control Group):
Normal saline infusion with identical timing and volume as the intervention group.
Desflurane administered at 1 MAC with EtControl mode
干预措施: Desflurane + Normal Saline (Drug)
结局指标
主要结局
Average Desflurane consumption per hour (mL/h) during surgery.
时间窗: During surgery
Average Desflurane consumption per hour (mL/h) during surgery.
次要结局
未报告次要终点