Liver DiseaseNCT01148277
Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
A study testing Propofol and Remifentnyl, midazolam and fentanyl and midazolam anf fentanyl in people with Liver Disease, run by Ziv Hospital at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Disease
- What is being tested?
- Propofol and Remifentnyl, midazolam and fentanyl and midazolam anf fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv medical center liver unit
Safed, Israel, 13100
Nimer Assy, MD, +972-46828445, assy.n@ziv.health.gov.il
About this study
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.
- Conditions
- Liver Disease
- Being tested
- Propofol and Remifentnyl, midazolam and fentanyl, midazolam anf fentanyl
- Keywords
- Endoscopies, Liver diseases, Propofol, Midazolam and remifentanyl
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol and RemifentnylDrug
Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist
midazolam and fentanylDrug
Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist
midazolam anf fentanylDrug
group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist
| Study group | Role | What they receive |
|---|---|---|
| Propofol and Remifentanyl | Active comparator | Propofol, colonoscopies, liver diseases, cirrhosis Receives: Drug: Propofol and Remifentnyl |
| midazolam and fentanyl | Active comparator | midazolam and fentanyl, colonoscopies, liver diseases Receives: Drug: midazolam and fentanyl |
| control midazolam anf fentanyl | Experimental | midazolam anf fentanyl Receives: Drug: midazolam anf fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of propofol in liver diseases
At the end of each endoscopy
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148277
- Sponsor's protocol ID
- Propofol vs Midazolam
- Status last verified
- Jun 2010
- First submitted
- 13 Jun 2010
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
- ClinicalTrials.gov ID
- NCT01148277
- Acronym / sponsor ID
- Propofol vs Midazolam
- Conditions
- Liver Disease
- Keywords
- Endoscopies, Liver diseases, Propofol, Midazolam and remifentanyl
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol and Remifentanyl | Active comparator | Drug: Propofol and RemifentnylPropofol, colonoscopies, liver diseases, cirrhosis |
| midazolam and fentanyl | Active comparator | Drug: midazolam and fentanylmidazolam and fentanyl, colonoscopies, liver diseases |
| control midazolam anf fentanyl | Experimental | Drug: midazolam anf fentanylmidazolam anf fentanyl |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol and RemifentnylIntervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist | Drug | Propofol and Remifentanyl |
| midazolam and fentanylIntervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist | Drug | midazolam and fentanyl |
| midazolam anf fentanylgroup (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist | Drug | control midazolam anf fentanyl |
Primary outcome
Safety and efficacy of propofol in liver diseases
Time frame: up to 3 hours
At the end of each endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Remifentnyl, midazolam and fentanyl and midazolam anf fentanyl in people with Liver Disease, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assy Nimer, MD (+97246828445, ASSY.N@ZIV.HEALTH.GOV.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of propofol in liver diseases (time frame: up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.