Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-pharmacological Intervention for Colonoscopy

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.
 
ClinicalTrials.gov Identifier: NCT00913861
Recruitment Status : Terminated (affiliation's change of the principal investigator need a new review bord)
First Posted : June 4, 2009
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Cheseaux Nicole, University Hospital, Geneva

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Colonoscopy Sedation Hypnosis Behavioral: hypnosis Drug: standard sedation Behavioral: Structured attention Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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?
Study Start Date : May 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Propofol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. gastroenterologist's satisfaction and quality of the colonoscopy [ Time Frame: the day of the procedure, at the end of the procedure ]
  2. vital parameters [ Time Frame: during all the procedure, every 5 minutes ]
  3. patient's comfort [ Time Frame: during the procedure every 10 minutes and 1 and 14 days after the colonoscopy ]
  4. 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 ]
  5. 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 ]
  6. duration of the procedure [ Time Frame: the day of the procedure ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Switzerland
Division of Anesthesiology, University Hospitals of Geneva
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Layout table for investigator information
Principal Investigator: Nicole Cheseaux, MD Division of Anesthesiology, University Hospitals, Geneva
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Cheseaux Nicole, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00913861    
Other Study ID Numbers: 08-238
NAC 08-072
First Posted: June 4, 2009    Key Record Dates
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:
Layout table for MeSH terms
Fentanyl
Propofol
Hypnotics and Sedatives
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