Comparing Time to Readiness for Discharge After Colonoscopy: Propofol and Dexmedetomidine vs Propofol Only Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure
研究概览
简要总结
An ideal sedative for colonoscopy should have properties that include: rapid onset and offset of action, provide cardiopulmonary stability, have minimal adverse effects, and allow for smooth recovery, and early discharge. Propofol is often used solely because of its rapid onset and short duration of action---a property which is ideal for a fast recovery and early discharge in the ambulatory setting. However, the use of propofol has been associated with undesirable effects such as hypotension, hypoventilation and apnea requiring assisted ventilation.
Balanced anesthesia, using a combination of medications with different mechanisms of action can reduce the total amount of each sedative agent used and minimize their side effects while achieving the desired level of sedation. Dexmedetomidine is one agent that has been used either alone or in combination with propofol for sedation during colonoscopy. While there are many advantages to using dexmedetomidine, there is concern that the use of this agent for sedation during colonoscopy may prolong post-operative recovery time and readiness for discharge home.
No study has definitively assessed whether the use of dexmedetomidine in combination with propofol during ambulatory colonoscopy prolongs post-operative recovery time as determined by the Modified Post Anesthesia Discharge Scoring System (MPADSS).
详细描述
In this study, investigators plan to prospectively compare in a randomized, controlled, double-blind trial, the sedation technique for colonoscopy between two groups. Group 1: sedation with dexmedetomidine and propopfol versus group 2: sedation with saline placebo and propofol.
The study will have the following outcome measures for each group.
Primary outcome measure:
Readiness-for-discharge (RFD) at 10, 20 and 30 minutes after the colonoscopic procedure. Ready-for-discharge is defined as attainment of MPADSS score of 9-10.
Secondary outcome measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients scheduled to undergo colonoscopy at SUNY Downstate Medical Center.
排除标准
- •< 18 years old
- •> 75 years old
- •Cognitively Impaired patients (Cognitively impaired patients are excluded from the study because our primary outcome involves a very strict discharge criteria that requires the patient to respond to and perform tasks on our pre-existing discharge scale checklist. These may be impossible to assess or will be difficult to standardize for patients whom are Cognitively Impaired.)
- •Pregnant patients
- •Patients who use a wheelchair or ambulates with crutches (Patients using a wheelchair are excluded from the study because our primary outcome involves a very strict discharge criteria that requires the patient to respond to and perform tasks on our pre-existing discharge scale checklist. These may be impossible to assess or will be difficult to standardize for patients whom who use a wheel-chair).
- •Limited exercise tolerance (as this could represent active coronary disease)
- •Total body weight greater than 105 kg (due to maximal dose of drug available in randomized syringes containing study drug)
- •Propofol, soy, glycerol or dexmedetomidine allergy
- •Significant renal impairment
- •Significant hepatic impairment
- •Inability to read or write in English
研究组 & 干预措施
Saline placebo and propofol
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
干预措施: Propofol (Drug)
Dexmedetomidine and propofol
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine and propofol
Intravenous dexmedetomidine 0.3 ug/kg followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
干预措施: Propofol (Drug)
Saline placebo and propofol
Intravenous saline placebo followed by propofol. Titrated doses of propofol will be given at the discretion of the anesthesiologist based on a target BIS range between 60-70.
干预措施: Saline placebo (Other)
结局指标
主要结局
Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure
时间窗: 30 minutes
Each subject was assessed for readiness for discharge at 10, 20 and 30 minutes after the procedure, using the Modified Post-Anesthesia Discharge Scoring System (MPADSS). A subject getting an MPADS score of 9-10 is deemed ready for discharge. The percentage of subjects ready for discharge in each group at 10, 20 and 30 minutes will be measured as primary outcome.
次要结局
- Average Total Propofol Consumption Per Group(between 7 and 57 minutes (median 19 min))
- Number of Participants With Sustained Bradycardic Episodes(30 minutes)
- Lowest Intraoperative % Change in MAP From Baseline(30 minutes)
- Number of Participants With Apneic Episodes Intraoperatively Requiring Positive Pressure Ventilation(30 minutes)
研究者
Dennis Dimaculangan
Clinical Associate Professor
State University of New York - Downstate Medical Center