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Balanced Propofol Sedation Versus Propofol Alone Sedation in Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT01321047 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2011-03-23

No results posted yet for this study

Summary

Based on previous results, the investigators considered that sedation quality, complications, and procedure outcomes may not be different, however, propofol alone titration may have a fast recovery time than BPS and cost-effectiveness than balanced propofol sedation (BPS). In present study, the investigators therefore evaluate the time and sedation quality of patient recovery, cost-effectiveness, complication, and procedure outcomes between propofol alone and BPS in therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

Conditions

  • Conscious Sedation Failure During Procedure

Interventions

DRUG

Propofol

propofol (0.5 mg/kg body weight; 10 mg if age \> 70 or ASA class III-IV)

DRUG

BPS

midazolam (0.05 mg/kg body weight; 1 mg if age \> 70 or ASA class III-IV) fentanyl (50 µg; 25 µg if age \> 70 or ASA class III-IV) propofol (0.5 mg/kg body weight)

Sponsors & Collaborators

  • Soon Chun Hyang University

    lead OTHER

Principal Investigators

  • Tae Hoon Lee, MD · Soonchunhyang University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-09-30
Completion
2011-10-31

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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 NCT01321047 on ClinicalTrials.gov