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| ID | Type | Description | Link |
|---|---|---|---|
| NAC 08-072 |
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affiliation's change of the principal investigator need a new review bord
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard sedation | Active Comparator | propofol and fentanyl |
|
| structured attention-standard sedation | Active Comparator | structured attention |
|
| hypnosis-standard sedation | Experimental | hypnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypnosis | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| total dose of propofol | the day of the colonoscopy, at the end |
| Measure | Description | Time Frame |
|---|---|---|
| gastroenterologist's satisfaction and quality of the colonoscopy | the day of the procedure, at the end of the procedure | |
| vital parameters | during all the procedure, every 5 minutes | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Cheseaux, MD | Division of Anesthesiology, University Hospitals, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Anesthesiology, University Hospitals of Geneva | Geneva | Canton of Geneva | CH-1211 | Switzerland |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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|
| standard sedation | Drug | Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0. |
|
|
| Structured attention | Behavioral | Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations. |
|
|
| patient's comfort |
| during the procedure every 10 minutes and 1 and 14 days after the colonoscopy |
| anxiety state | between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure |
| patient's satisfaction | between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy |
| duration of the procedure | the day of the procedure |
| D004191 |
| Behavioral Disciplines and Activities |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |