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This is a prospective, randomized-controlled trial (RCT) comparing the use of Propofol and Remifentanyl and traditional sedation (Midazolam and Fentanyl) for diagnostic colonoscopies in patients with compensated cirrhosis child A-B. The working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications (Hepatic Encephalopathy) in the context of patients with advanced liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol and Remifentanyl | Active Comparator | Propofol, colonoscopies, liver diseases, cirrhosis |
|
| midazolam and fentanyl | Active Comparator | midazolam and fentanyl, colonoscopies, liver diseases |
|
| control midazolam anf fentanyl | Experimental | midazolam anf fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol and Remifentnyl | Drug | Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy of propofol in liver diseases | At the end of each endoscopy | up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Assy Nimer, MD | Contact | +97246828445 | ASSY.N@ZIV.HEALTH.GOV.IL |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziv medical center liver unit | Safed, Israel | 13100 | Israel |
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| midazolam and fentanyl | Drug | Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist |
|
| midazolam anf fentanyl | Drug | group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist |
|
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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