Non-pharmacological Intervention for Colonoscopy

Overview

The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.

Full Title of Study: “Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2014

Detailed Description

Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.

Interventions

  • Behavioral: hypnosis
    • Hypnosis: induction of hypnosis by visual fixation and recollection of a pleasant memory, suggestion of relaxation, of self-control and post-hypnotic suggestion for bowel relaxation.
  • Drug: standard sedation
    • Standard sedation: fentanyl 2×0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.
  • Behavioral: Structured attention
    • Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations.

Arms, Groups and Cohorts

  • Active Comparator: standard sedation
    • propofol and fentanyl
  • Active Comparator: structured attention-standard sedation
    • structured attention
  • Experimental: hypnosis-standard sedation
    • hypnosis

Clinical Trial Outcome Measures

Primary Measures

  • total dose of propofol
    • Time Frame: the day of the colonoscopy, at the end

Secondary Measures

  • gastroenterologist’s satisfaction and quality of the colonoscopy
    • Time Frame: the day of the procedure, at the end of the procedure
  • vital parameters
    • Time Frame: during all the procedure, every 5 minutes
  • patient’s comfort
    • Time Frame: during the procedure every 10 minutes and 1 and 14 days after the colonoscopy
  • anxiety state
    • Time Frame: between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure
  • patient’s satisfaction
    • Time Frame: between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy
  • duration of the procedure
    • Time Frame: the day of the procedure

Participating in This Clinical Trial

Inclusion Criteria

  • patients classified as ASA 1 to 3 – colonoscopy with anesthesiological support – capacity of consenting Exclusion Criteria:

  • pregnancy – colonoscopy with gastroscopy – emergency – psychotic diseases – deafness – incapacity to understand french – addiction of drugs and alcohol – psychoactive drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Geneva
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cheseaux Nicole, MD – University Hospital, Geneva
  • Overall Official(s)
    • Nicole Cheseaux, MD, Principal Investigator, Division of Anesthesiology, University Hospitals, Geneva

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