Liver CirrhosisNCT00978978
Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
A study testing Propofol VS. midazolam and fentanyl, endoscopies, liver diseases in people with Liver Cirrhosis, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Aug 2010
- 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 advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)
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 or those with mild degree of liver fibrosis (less than F3)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Gastroenterology. Soroka University Medical Center
Beersheba, Beer-Sheva, 84101
Jorge-Shmuel Delgado, MD, delgado@bgu.ac.il
Jorge-Shmuel Delgado, MD
About this study
Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' 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 in the context of patients with advanced liver disease.
- Conditions
- Liver Cirrhosis
- Being tested
- Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol VS. midazolam and fentanyl, endoscopies, liver diseasesDrug
- Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists'
- Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists
| Study group | Role | What they receive |
|---|---|---|
| Propofol, endoscopies, liver diseases | Active comparator | Propofol, endoscopies, liver diseases Receives: Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases |
| midazolam and fentanyl, endoscopies, liver diseases | Active comparator | Control: midazolam and fentanyl, endoscopies, liver diseases Receives: Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases |
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
Measured: At the end of each endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978978
- Sponsor's protocol ID
- SOR484909CTIL
- Status last verified
- Sep 2009
- First submitted
- 16 Sep 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
- ClinicalTrials.gov ID
- NCT00978978
- Acronym / sponsor ID
- SOR484909CTIL
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (estimated)
- First posted
- 17 Sep 2009 (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.
Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' 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 in the context of patients with advanced liver disease.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol, endoscopies, liver diseases | Active comparator | Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseasesPropofol, endoscopies, liver diseases |
| midazolam and fentanyl, endoscopies, liver diseases | Active comparator | Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseasesControl: midazolam and fentanyl, endoscopies, liver diseases |
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 advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)
Key exclusion criteria (1 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 or those with mild degree of liver fibrosis (less than F3)
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 VS. midazolam and fentanyl, endoscopies, liver diseases1. Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists' 2. Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists | Drug | Propofol, endoscopies, liver diseases, midazolam and fentanyl, endoscopies, liver diseases |
Primary outcome
Safety and efficacy of propofol in liver diseases
Time frame: 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 14 Oct 2009.
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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 VS. midazolam and fentanyl, endoscopies, liver diseases in people with Liver Cirrhosis, run by Soroka University Medical Center 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 1 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 14 Oct 2009. 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 Jorge-Shmuel Delgado, MD (972-8-6403164, delgado@bgu.ac.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: At the end of each endoscopy). 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 14 Oct 2009.