Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sedation
研究概览
简要总结
Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.
详细描述
Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
A blinded investigator that was not involved in the anaesthetic management of the patients, collected the intra-operative and postoperative data. The patients and colonoscopist were blinded to group allocation. For blinding purposes, two drug infusion pumps were used in every patient where the infusion pumps and i.v. connection lines were concealed to avoid identification.
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
- •ASA I or II physical status
- •18-65 years
- •Scheduled for elective colonoscopy
排除标准
- •History of allergy to any of the study drugs
- •Alcohol or drug abuse.
- •Second and third-degree heart block.
- •Morbid obesity.
- •Pregnant and lactating women.
- •Psychiatric disorders.
- •Severe cardiac, respiratory, renal, and liver diseases
研究组 & 干预措施
(Dexmedetomidine)Dex group
The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure
干预措施: Dexmedetomidine (Drug)
Propofol-Remifentanil (P-R) group
Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min.
干预措施: Propofol (Drug)
Propofol-Remifentanil (P-R) group
Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Sedation
时间窗: Perioperative
Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.
次要结局
- Oxygen saturation(Perioperative)
- Hypotension(Perioperative)
- Bradycardia(Perioperative)
- Mean arterial blood pressure(Perioperative)
- Heart rate(Perioperative)
- Analgesia(Perioperative)
研究者
Abd-Elazeem Abd-Elhameed Elbakry
Associate professor of anaesthesia
Menoufia University