NCT00906139

Brief Summary

The purpose of this study is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic upper gastrointestinal endoscopy (UGE) in cirrhotic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

May 25, 2009

Status Verified

May 1, 2009

Enrollment Period

11 months

First QC Date

May 20, 2009

Last Update Submit

May 22, 2009

Conditions

Cirrhosis

Keywords

PropofolMidazolamCirrhosisGastrointestinal endoscopyComplicationsSedation

Outcome Measures

Primary Outcomes (1)

  • To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency

    Three months

Study Arms (2)

Propofol

ACTIVE COMPARATOR

To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);

Drug: PropofolDrug: Fentanyl

Midazolam

ACTIVE COMPARATOR

To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).

Drug: MidazolamDrug: Fentanyl

Interventions

PropofolDRUG

Propofol dose: 0.5 mg/kg up to 400 mg

Propofol
MidazolamDRUG

Midazolam dose: 0.1 mg/kg

Midazolam
FentanylDRUG

Fentanyl dose: 0.05 mg

MidazolamPropofol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver cirrhosis, any etiology
  • ASA II or III
  • Child A, B or C
  • Age between 18 years and 75 years
  • Patients that agree in participate of study and signed the contentment term

You may not qualify if:

  • Schistosomiasis
  • Recuse
  • Hepatocellular carcinoma
  • Contraindications to drugs
  • ASA IV or V
  • Hepatic encephalopathy, neurologic diseases
  • Opioids, narcotics, MAO inhibitors or benzodiazepines use
  • Alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Fibrosis

Interventions

PropofolMidazolamFentanyl

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

March 1, 2008

Primary Completion

February 1, 2009

Study Completion

November 1, 2009

Last Updated

May 25, 2009

Record last verified: 2009-05

Locations

BR(1)