A Psychomotor Recuperation Study After Deep Sedation for Colonoscopy Between Target Controlled and Manual Titration of Propofol
Condition: Colonoscopy (Ambulatory Patients)
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Manual titration of propofol; Target controlled infusion of propofol
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: propofol; colonoscopy