Non-pharmacological Intervention for Colonoscopy

Colonoscopy Clinical Trial

Official title:

Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00913861
• Other study ID #: 08-238
• Secondary ID: NAC 08-072
• Status: Terminated
• Phase: N/A
• First received: May 22, 2009
• Last updated: June 2, 2014
• Start date: May 2009
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy
• Hypnosis
• Sedation

Intervention

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.

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.

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.

Locations

Country	Name	City	State
Switzerland	Division of Anesthesiology, University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total dose of propofol		the day of the colonoscopy, at the end	No
Secondary	gastroenterologist's satisfaction and quality of the colonoscopy		the day of the procedure, at the end of the procedure	No
Secondary	vital parameters		during all the procedure, every 5 minutes	Yes
Secondary	patient's comfort		during the procedure every 10 minutes and 1 and 14 days after the colonoscopy	No
Secondary	anxiety state		between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure	No
Secondary	patient's satisfaction		between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy	No
Secondary	duration of the procedure		the day of the procedure	No