Sedation for Colonoscopy Procedures Using Dexmedetomidine Versus Propofol-Fentanyl Infusions: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The quality of painless sedation during colonoscopy.
研究概览
简要总结
Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.
详细描述
Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.
Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-60 years old, with
- •ASA physical status -
排除标准
- •severe cardiovascular or respiratory disease
- •(ASA grade ≥III)
- •pregnancy
- •allergies to the drugs being used
- •known alcohol or substance abuse
- •expected communication difficulties with the patient.
研究组 & 干预措施
D group
Patients who received Dexmedetomidine. The starting dose of dexmedetomidine was 1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h).
干预措施: Patients who received Dexmedetomodine (Drug)
PF group
Patients who received Propofol-Fentanyl infusions. Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.
干预措施: patients who received propofol-fentanyl (Drug)
结局指标
主要结局
The quality of painless sedation during colonoscopy.
时间窗: From start of procedure to 120 minutes after end of colonoscopy
The patient's ability to cooperate and perform the procedure was evaluated using a 10-point numerical rating scale (NRS).
次要结局
- incidence of adverse events, Prevalence of adverse effects(from start of procedure to 120 minutes after end of colonoscopy)