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

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ClinicalTrials.gov Identifier: NCT02314559
Recruitment Status : Recruiting
First Posted : December 11, 2014
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Philippe VAN DER LINDEN, Brugmann University Hospital

Tracking Information
First Submitted Date  ICMJE December 5, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date May 31, 2018
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • Digit Symbol Substitution test score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02314559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Psychomotor Recuperation Study After Deep Sedation for Colonoscopy Between Target Controlled and Manual Titration of Propofol
Official Title  ICMJE A Psychomotor Recuperation Study After Deep Sedation for Colonoscopy Between Target Controlled and Manual Titration of Propofol.
Brief 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.

Detailed Description

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.

As psychomotor test, the investigators chose a choice reaction time test for its sensitivity to detect minor changes after propofol sedation. This test has also validity in alcohol intoxication. A simple reaction time test is also included for its easy applicability and obtainability in everyday practive. Test results will be compared to see if there is a correlation with the choice reaction time tests.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Colonoscopy (Ambulatory Patients)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Propofol (manual titration)
    Intervention: Drug: Manual titration of propofol
  • Active Comparator: Propofol (target controlled infusion)
    Intervention: Drug: Target controlled infusion of propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients subjected to deep sedation in ambulant care, having a colonoscopy
  • ASA 1-3

Exclusion Criteria:

  • Dementia.
  • Gastroscopy planned at the same time.
  • Allergies to propofol
  • All cases were a 'full stomach' is suspected (gastric banding)
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hans Verdoodt, MD hans.verdoodt@chu-brugmann.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02314559
Other Study ID Numbers  ICMJE CHUB Mental Recup 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philippe VAN DER LINDEN, Brugmann University Hospital
Study Sponsor  ICMJE Brugmann University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hans Verdoodt, MD CHU Brugmann
Principal Investigator: Philippe Vanderlinden, MD, Pr CHU Brugmann
PRS Account Brugmann University Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP