Non-pharmacological Intervention for Colonoscopy

June 2, 2014 updated by: Cheseaux Nicole, University Hospital, Geneva

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, CH-1211
        • Division of Anesthesiology, University Hospitals of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • hypnotic state

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
gastroenterologist's satisfaction and quality of the colonoscopy
Time Frame: the day of the procedure, at the end of the procedure
the day of the procedure, at the end of the procedure
vital parameters
Time Frame: during all the procedure, every 5 minutes
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
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
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
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
the day of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Nicole Cheseaux, MD, Division of Anesthesiology, University Hospitals, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (ESTIMATE)

June 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-238
  • NAC 08-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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