We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-pharmacological Intervention for Colonoscopy

This study has been terminated.
(affiliation's change of the principal investigator need a new review bord)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913861
First Posted: June 4, 2009
Last Update Posted: June 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cheseaux Nicole, University Hospital, Geneva
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Cheseaux Nicole, University Hospital, Geneva:

Primary Outcome Measures:
  • total dose of propofol [ Time Frame: the day of the colonoscopy, at the end ]

Secondary Outcome 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cheseaux Nicole, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00913861     History of Changes
Other Study ID Numbers: 08-238
NAC 08-072
First Submitted: May 22, 2009
First Posted: June 4, 2009
Last Update Posted: June 3, 2014
Last Verified: June 2014

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

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