Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

NCT01356121 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-05-19

No results posted yet for this study

Summary

To compare effects of sedation for upper gastrointestinal endoscopy with propofol and midazolam on psychometric tests and critical flicker frequency (CFF) in cirrhotics

Conditions

  • Hepatic Encephalopathy

Interventions

DRUG

Propofol

Propofol will be initiated with a .5-1 mg/kg i.v. bolus followed by repeated 10-20 mg doses at variable intervals (approximately 15 s, at the discretion of the endoscopist/nurse) until an appropriate level of sedation will be achieved.

DRUG

Midazolam

Midazolam (0.5-1.0 mg) will be administered in a similar fashion with incremental dosing at intervals of approximately 1-3 min until a level of sedation will be achieved

Sponsors & Collaborators

  • Govind Ballabh Pant Hospital

    lead OTHER_GOV

Principal Investigators

  • Barjesh C Sharma, MD,DM · Govind Ballabh Pant Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01356121 on ClinicalTrials.gov