Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

NCT01488045

Colon Cancer Rectal Cancer Colonic Diverticulosis

COMPLETED NA

The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

NCT00376831

Colonoscopy Conscious Sedation

COMPLETED PHASE4

Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

NCT01141036

Cirrhosis

COMPLETED NA

Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy

NCT01934088

Inflammatory Bowel Disease Endoscopy Sedation

COMPLETED PHASE4

Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy

NCT01428882

Procedural Sedation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Propofol, endoscopies, liver diseases

Group Type ACTIVE_COMPARATOR

Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

Intervention Type DRUG

1. 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

midazolam and fentanyl, endoscopies, liver diseases

Control: midazolam and fentanyl, endoscopies, liver diseases

Group Type ACTIVE_COMPARATOR

Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

Intervention Type DRUG

1. 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

1. 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

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 or those with mild degree of liver fibrosis (less than F3)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No