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Non-pharmacological Intervention for Colonoscopy

This study has been terminated.
(affiliation's change of the principal investigator need a new review bord)
Sponsor:
Information provided by (Responsible Party):
Cheseaux Nicole, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00913861
First received: May 22, 2009
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Colonoscopy
Sedation
Hypnosis
Behavioral: hypnosis
Drug: standard sedation
Behavioral: Structured attention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • total dose of propofol [ Time Frame: the day of the colonoscopy, at the end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard sedation
propofol and fentanyl
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
Active Comparator: structured attention-standard sedation
structured attention
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
Experimental: hypnosis-standard 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913861

Locations
Switzerland
Division of Anesthesiology, University Hospitals of Geneva
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Nicole Cheseaux, MD Division of Anesthesiology, University Hospitals, Geneva
  More Information

No publications provided

Responsible Party: Cheseaux Nicole, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00913861     History of Changes
Other Study ID Numbers: 08-238, NAC 08-072
Study First Received: May 22, 2009
Last Updated: June 2, 2014
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:
endoscopy
comfort
non-pharmacological

Additional relevant MeSH terms:
Fentanyl
Propofol
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014