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Safety and Efficacy of Fentanyl Versus Pethidine During Propofol-based Sedated Colonoscopy: Prospective Randomized Study

NCT02039453 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-01-17

No results posted yet for this study

Summary

During sedative colonoscopy, use of propofol have been increased world wide. The onset time of propofol is shorter than midazolam. However the most popular additive pain killer, pethidine show different pharmacodynamic feature. The pethidine has longer onset time than propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl was not studied. Therefore, we designed this study to compare both drug to check satisfaction of this drug.

Conditions

  • Health Check up Colonoscopy

Interventions

DRUG

fentanyl doses

fentanyl doses 50μg (37.5kg to 62.5kg), 75μg (62.5kg to 87.5kg), 100μg (\>87.5kg), single use Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)

DRUG

pethidine dose

pethidine dose 50mg, IV bolus (25mg if \< 50kg or \>70 years or significant co-morbidity), Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • South Korea

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 NCT02039453 on ClinicalTrials.gov