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Non-Pharmacological Intervention for Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00913861
First received: May 22, 2009
Last updated: June 3, 2009
Last verified: May 2009
History of Changes

May 22, 2009
June 3, 2009
May 2009
May 2010   (final data collection date for primary outcome measure)
total dose of propofol [ Time Frame: the day of the colonoscopy, at the end ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00913861 on ClinicalTrials.gov Archive Site
  • gastroenterologist's satisfaction and quality of the colonoscopy [ Time Frame: the day of the procedure, at the end of the procedure ] [ Designated as safety issue: No ]
  • vital parameters [ Time Frame: during all the procedure, every 5 minutes ] [ Designated as safety issue: Yes ]
  • patient's comfort [ Time Frame: during the procedure every 10 minutes and 1 and 14 days after the colonoscopy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • duration of the procedure [ Time Frame: the day of the procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Non-Pharmacological Intervention for Colonoscopy
Does Non-Pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Colonoscopy
  • Sedation
  • HYPNOSIS
  • 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.
    Other Name: hypnotic state
  • Drug: standard sedation
    Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.
    Other Name: Disoprivan (propofol)and fentanyl
  • 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.
    Other Name: psychological support
  • Active Comparator: standard sedation
    propofol and fentanyl
    Intervention: Drug: standard sedation
  • Active Comparator: structured attention-standard sedation
    structured attention
    Intervention: Behavioral: Structured attention
  • Experimental: hypnosis-standard sedation
    hypnosis
    Intervention: Behavioral: hypnosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nicole Cheseaux, MD 0041 22 372 74 15 nicole.cheseaux@hcuge.ch
Switzerland
 
NCT00913861
08-238, NAC 08-072
No
Cheseaux Nicole, Divsion of Anesthesiology, University Hospitals Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Nicole Cheseaux, MD Division of Anesthesiology, University Hospitals, Geneva
University Hospital, Geneva
May 2009

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