Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Ziv Hospital.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Ziv Hospital
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01148277
First received: June 13, 2010
Last updated: April 5, 2011
Last verified: June 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Liver Disease |
Drug: Propofol and Remifentnyl Drug: midazolam and fentanyl Drug: midazolam anf fentanyl |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
Drug Information available for:
Fentanyl
Fentanyl citrate
Propofol
Midazolam hydrochloride
Remifentanil hydrochloride
U.S. FDA Resources
Further study details as provided by Ziv Hospital:
Primary Outcome Measures:
- Safety and efficacy of propofol in liver diseases [ Time Frame: up to 3 hours ] [ Designated as safety issue: Yes ]At the end of each endoscopy
| Estimated Enrollment: | 90 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Propofol and Remifentanyl
Propofol, colonoscopies, liver diseases, cirrhosis
|
Drug: Propofol and Remifentnyl
Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist
|
|
Active Comparator: midazolam and fentanyl
midazolam and fentanyl, colonoscopies, liver diseases
|
Drug: midazolam and fentanyl
Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist
|
|
Experimental: control midazolam anf fentanyl
midazolam anf fentanyl
|
Drug: midazolam anf fentanyl
group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Consecutive patients older than 18 and younger than 75 years with cirrhosis defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B)
Exclusion Criteria:
- Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea.
- HCC
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148277
Contacts
| Contact: Assy Nimer, MD | +97246828445 | ASSY.N@ZIV.HEALTH.GOV.IL |
Locations
| Israel | |
| Ziv medical center liver unit | Not yet recruiting |
| Safed, Israel, Israel, 13100 | |
| Contact: Nimer Assy, MD +972-46828445 assy.n@ziv.health.gov.il | |
Sponsors and Collaborators
Ziv Hospital
More Information
No publications provided
| Responsible Party: | Liver Clinic, Ziv medical center |
| ClinicalTrials.gov Identifier: | NCT01148277 History of Changes |
| Other Study ID Numbers: | Propofol vs Midazolam |
| Study First Received: | June 13, 2010 |
| Last Updated: | April 5, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Ziv Hospital:
|
Endoscopies Liver diseases Propofol Midazolam and remifentanyl |
Additional relevant MeSH terms:
|
Fibrosis Liver Diseases Liver Cirrhosis Pathologic Processes Digestive System Diseases Midazolam Fentanyl Propofol Remifentanil Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013