The Effects of Dexmedetomidine and Remifentanil on Sedation and Comfort in Non-Operating Room Anesthesia: A Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Agitation-Sedation
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) procedure is frequently encountered in non-operating room anesthesia applications (NORA). It is a procedure that requires deep sedation and analgesia in terms of gastroenterologist and patient comfort. Dexmedetomidine, which is increasingly used in NORA applications, comes to the fore because it does not cause respiratory depression, reduces the stress response, and provides hemodynamic stability. This study aims to compare the effects of dexmedetomidine-propofol (DP) and remifentanil-propofol (RP) combinations on hemodynamic stability, rapid recovery, and patient comfort in patients who underwent ERCP.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Neurological disease,
- •Psychiatric disease,
- •Coronary artery disease,
- •Long-term sedative drug use,
- •Pregnant patients,
- •Known allergy to planned drugs
研究组 & 干预措施
Group Dex
Group Dex received 0.5 mcg/kg of dexmedetomidine IV for 10 minutes, then dexmedetomidine infusion was started at 0.1-0.7 mcg/kg/h. Propofol 1 mg/kg was administered after waiting for 5 minutes for adequate sedation to develop due to dexmedetomidine's delayed onset of action.
干预措施: Dexmedetomidine (Drug)
Group Remi
Group RP received remifentanil 0.1 mcg/kg intravenously for 2 minutes, then remifentanil infusion was started at 0.01-0.1 mcg/kg/min. After waiting 2 minutes to develop a sufficient sedation level, 1 mg/kg of propofol was given.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Agitation-Sedation
时间窗: 0 and 5 minutes after ERCP ends
It will be evaluated with a Richmond Agitation-Sedation Scale.
Hemodynamic stability
时间窗: 5, 10, 15, 25, 35. minutes
Mean arterial pressure with non-invasive blood pressure monitoring (mmHg)
次要结局
- Minimize drug dose(5, 10, 15, 25, 35. minutes)
- Rapid recovery(30 minutes after ERCP ends)
- Patient comfort(30 minutes after ERCP ends)
研究者
Ahmed Uslu
MD, Research assistant
Baskent University Ankara Hospital