Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)
研究概览
简要总结
This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.
详细描述
This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.
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 (Care Provider, Outcomes Assessor)
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
- 是
入选标准
- •ASA I or II patients
- •aged between 18 to 80 years
- •scheduled for outpatient colonoscopy
排除标准
- •history of or with psychiatric disease
- •on psychoactive drugs
- •mentally or physically unable to use the hand-held device for PCS
- •previous complications from anaesthesia or sedation
- •potentially difficult airway maintenance
- •obstructive sleep apnoea
- •with contraindications to the study drugs
研究组 & 干预措施
TCI propofol
Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale
干预措施: Propofol 10 MG/ML Injection (Drug)
TCI propofol
Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale
干预措施: target controlled infusion pump (Device)
PCS propofol
Patient-controlled sedation titrated by the patient to comfort level
干预措施: Propofol 10 MG/ML Injection (Drug)
PCS propofol
Patient-controlled sedation titrated by the patient to comfort level
干预措施: patient-controlled sedation pump (Device)
midazolam and pethidine
Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation
干预措施: Midazolam injection (Drug)
midazolam and pethidine
Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation
干预措施: Pethidine Hydrochloride 50 Mg/mL Solution for Injection (Drug)
结局指标
主要结局
Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)
时间窗: From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery
Recovery of patient from sedation when MOAAS 5 is achieved
Recovery time to ambulation
时间窗: From time of arrival at the recovery area after completion of colonoscopy, until the point patient starts to ambulate, assessed up to 2 hours post arrival at recovery
Recovery of patient from sedation when patient starts ambulating
Recovery time to discharge
时间窗: From time of arrival at the recovery area after completion of colonoscopy, until the point patient is deemed fit for discharge home, assessed up to 2 hours post arrival at recovery
Recovery of patient from sedation when patient is deemed fit for discharge home
Endoscopist satisfaction score
时间窗: After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy
After completion of colonoscopy, the endoscopist graded on a scale of 1 to 10, ease of the colonoscopy/procedure (1 = very difficult, 10 = very easy), and level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
Patient satisfaction score
时间窗: Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation
After completion of colonoscopy, the patient graded on a scale of 1 to 10, the level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
Patient willingness to repeat the same sedation technique
时间窗: From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery
Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future
次要结局
- Rescue analgesic drug requirement(From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation)
- Total drug consumption(Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy, assessed up to 2 hours from the start of sedation)
- Ease of colonoscopy score(during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy)
- Recalled events during colonoscopy(Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery)
- Recalled discomfort/ pain during colonoscopy(Recalled events of discomfort/pain retrived from the patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery)
研究者
Nadia Md Nor
Primary Investigator, consultant anaesthesiologist
Universiti Kebangsaan Malaysia Medical Centre