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临床试验/NCT02314559
NCT02314559已完成4 期

A Psychomotor Recuperation Study After Deep Sedation for Colonoscopy Between Target Controlled and Manual Titration of Propofol.

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
164
试验地点
1
主要终点
Choice reaction time test score

研究概览

简要总结

Deep sedation with propofol for ambulatory colonoscopy has become standard clinical practice.To achieve the necessary (e.g.: no excessive movement and no awareness) level of sedation during colonoscopy, propofol can be titrated by hand, continuous infusion or by target controlled infusion.

The aim of the investigators is to evaluate sedation efficacy and recovery between two groups of ambulatory patients having a colonoscopy: one group will receive a manual titration of propofol, the other group a target controlled infusion (TCI) of propofol. The investigators will evaluate both groups before, during and after colonoscopy for adverse events, quality of sedation and recovery. When patients are estimated to be ready for discharge, they will also be subjected to a cognitive and a psychomotoricity test.

详细描述

Deep sedation with propofol for ambulatory colonoscopy has become standard clinical practice. Fewer adverse events and a faster wake up time than with the use of benzodiazepines are proven. A growing group of patients are subjected to this examination for diagnostic and screening purposes.

In most cases, patients can return home after a short recovery time, under the supervision of an accompanying person. Often, no residual effects are clinically detectable. Some studies advocate that driving skills recover quickly. Current guidelines however, insist to avoid driving or using public transportation alone for at least 12 hours (24 hours if other sedatives are used).

To achieve the necessary (e.g.: no excessive movement and no awareness) level of sedation during colonoscopy, propofol can be titrated by hand, continuous infusion or by target controlled infusion. Only one study, to the investigators knowledge, compares efficacy between manual titration and target controlled infusion of propofol in combination with fentanyl for bidirectional endoscopy.

The aim of the investigators is to evaluate sedation efficacy and recovery between two groups of ambulatory patients having a colonoscopy: one group will receive a manual titration of propofol, the other group a target controlled infusion (TCI) of propofol. The investigators will evaluate both groups before, during and after colonoscopy for adverse events, quality of sedation and recovery. When patients are estimated to be ready for discharge, they will also be subjected to a cognitive and a psychomotoricity test.

To evaluate cognitive function, the investigators will use the digit symbol substitution test. The digit symbol substitution test is popular for detecting deterioration in concentration. Here for 90 seconds, a test subject is asked to change a number in a symbol.

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
Triple (Participant, Investigator, 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

入选标准

  • All patients subjected to deep sedation in ambulant care, having a colonoscopy

排除标准

  • Dementia.
  • Gastroscopy planned at the same time.
  • Allergies to propofol
  • All cases were a 'full stomach' is suspected (gastric banding)
  • Pregnancy

研究组 & 干预措施

Propofol (manual titration)

Experimental

干预措施: Manual titration of propofol (Drug)

Propofol (target controlled infusion)

Active Comparator

干预措施: Target controlled infusion of propofol (Drug)

结局指标

主要结局

Choice reaction time test score

时间窗: 24 hours

The choice reaction time test score will be compared between the propofol manual titration and the propofol target controlled infusion groups. The groups will be tested before the colonoscopy and every 10 minutes after waking up, up to the discharge of the patient. This test is used to evaluate the psychomotoricity of the patients.

Digit Symbol Substitution test score

时间窗: 24 hours

The digit symbol substitution test score wil be compared between the propofol manual titration and the propofol target controled infusion groups. This test will evaluate cognitive function.

PADS score

时间窗: 24 hours

Time and fitness to discharge will be evaluated with the PADS score. This will be done at discharge of the patient, after the colonoscopy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis SCHMARTZ

Head of anesthesiology department

Brugmann University Hospital

研究点 (1)

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