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A Psychomotor Recuperation Study After Deep Sedation for Colonoscopy Between Target Controlled and Manual Titration of Propofol.
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.
Details
| Lead sponsor | Brugmann University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 164 |
| Start date | 2015-02 |
| Completion | 2020-07-07 |
Conditions
- Colonoscopy (Ambulatory Patients)
Interventions
- Manual titration of propofol
- Target controlled infusion of propofol
Primary outcomes
- Digit Symbol Substitution test score — 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 — 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. - Choice reaction time test score — 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.
Countries
Belgium