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

NCT02314559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2022-07-19

No results posted yet for this study

Summary

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.

Conditions

  • Colonoscopy (Ambulatory Patients)

Interventions

DRUG

Manual titration of propofol

One group will be sedated with a manual titration technique: here the titration of propofol is done manually by the anesthetist. Dosages may range between 50 and 400mg, given by boluses of 20-50mg.

DRUG

Target controlled infusion of propofol

The other group will be sedated with a target controlled infusion technique (pump, marsh or Schneider). The anesthetist can titrate indirectly by adjusting the target controlled infusion to achieve adequate sedation. The concentrations of propofol may vary between 2 and 6 µg/ml, achieved by increments of 0.5-1.5 µg/ml.

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • Denis Schmartz, MD · CHU Brugmann

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2020-07-07
Completion
2020-07-07

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314559 on ClinicalTrials.gov