Trials / Terminated
TerminatedNCT00913861
Non-pharmacological Intervention for Colonoscopy
Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- University Hospital, Geneva · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2009-06-04
- Last updated
- 2014-06-03
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT00913861. Inclusion in this directory is not an endorsement.