The Effects of Fentanyl and Alfentanil as an Adjunct to Propofol on Cognitive Functions for Sedation in Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- cognitive dysfunction
研究概览
简要总结
This study aims to compare the effects of fentanyl and alfentanil on postprocedural cognitive function in elective endoscopy.
150 patients will be enrolled in the study. Patients meeting eligibility criteria will be randomly allocated to three groups.
The patients in Group A will be given propofol and alfentanil. The patients in Group F will be given propofol and fentanyl. Group P is designated as the control group and the patients will be given propofol for sedation.
Awareness, vital signs and pain will be evaluated. Side effects will be recorded. Patient and endoscopist satisfaction will be evaluated.
详细描述
In this study we aimed to compare the effects of sedation provided by propofol with the addition of the short-acting opioid alfentanil and long-acting opioid fentanyl on cognitive functions, pain, side effects during the procedure and the endoscopist and patient satisfaction.
Following the approval of Kırıkkale University ethics committee, 150 patients ages between 18 and 65 ASA I-III scheduled for elective endoscopy and colonoscopy will be enrolled in the study.
After obtaining written informed consent, APAIS (The Amsterdam Preoperative Anxiety and Information Scale) and MMTS (Mini Mental Test Scoring) tests will given to patients. Following TDT (Trieger Dot Test) and DSST (Digit Symbol Substitution Test), the patients will be randomly allocated to either Propofol-Alfentanil (Group A), Propofol-Fentanyl (Group F) or Propofol-Control (Group P) which consists of 50 patients each.
The patients in Group A will be given 100 mcg/kg/min propofol infusion and 10 mcg/kg loading dose of alfentanil and 5 mcg/kg additional bolus of alfentanil whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure.
The patients in Group F will be given 100 mcg/kg/min propofol infusion and 1 mcg/kg loading dose of fentanyl and 5 mcg/kg additional bolus of fentanyl whenever FPS (Faces Pain Scale) is greater than 3 or the patients could not tolerate the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Ages between 18-65
- •American Society of Anesthesiologists classification I-III
- •Patients scheduled to undergo elective colonoscopy or endoscopy and colonoscopy
排除标准
- •Patients younger than 18 or older than 65
- •Mini mental test score < 26
- •APAIS (The Amsterdam Preoperative Anxiety and Information Scale) >10
- •Serious systemic disease
- •Neuropsychiatric disorder
- •Chronic alcohol abuse
- •Morbid obesity
- •History of anesthesia in the last 7 days
- •Known allergy to study drugs
研究组 & 干预措施
Group A
The patients in Group A will be given 100 mcg/kg/min propofol infusion and 10 mcg/kg loading dose of alfentanil and 5 mcg/kg additional bolus of alfentanil whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure.
干预措施: Alfentanil (Drug)
Group A
The patients in Group A will be given 100 mcg/kg/min propofol infusion and 10 mcg/kg loading dose of alfentanil and 5 mcg/kg additional bolus of alfentanil whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure.
干预措施: Propofol (Drug)
Group F
The patients in Group F will be given 100 mcg/kg/min propofol infusion and 1 mcg/kg loading dose of fentanyl and 5 mcg/kg additional bolus of fentanyl whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure.
干预措施: Fentanyl (Drug)
Group F
The patients in Group F will be given 100 mcg/kg/min propofol infusion and 1 mcg/kg loading dose of fentanyl and 5 mcg/kg additional bolus of fentanyl whenever FPS (Faces Pain Scale) is greater than 3 or the patients can not tolerate the procedure.
干预措施: Propofol (Drug)
Group P
Group P is designated as the control group and the patients will be given 100mcg/kg/min infusion and sedation will be achieved via 1 mg/kg propofol loading dose and 0.5 mg/kg propofol additional bolus will be given whenever the patients can not tolerate the procedure or FPS is greater than 3.
干预措施: Propofol (Drug)
结局指标
主要结局
cognitive dysfunction
时间窗: during the 30 minutes after the termination of the procedure
as evaluated using Trieger dot test,Mini mental test and Digit symbol substitution test
次要结局
- Patient and endoscopist satisfaction(following the procedure)
- Pain(during the 30 minutes after the termination of the procedure)
- Side effects(during the 30 minutes after the termination of the procedure)
研究者
Perihan Ekmekçi
Assistant Professor
Ufuk University