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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02039453
Enrollment
160
Registered
2014-01-17
Start date
2013-09-30
Completion date
2015-08-31
Last updated
2014-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Check up Colonoscopy

Keywords

Colonoscopy, sedation, propofol, fentanyl, pethidine

Brief 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.

Interventions

DRUGfentanyl 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)

DRUGpethidine 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

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* A patient who undergo screening colonoscopy with sedative agents * A patient over 20 years and under 65 years * A patient who agree to participate in this study

Exclusion criteria

* A patient who is refered from outside hospital to remove previously noted colon polyp * The case who cannot be achieved cecal intubation because of poor bowel preparation * A patient who undergo sedative EGD just prior to colonoscopy * A patient who have allergy to propofol, pethidine, or fentanyl * A patient who have taken MAO inhibitor regularly * A patient who underwent colon resection surgery before colonoscopy * A patient who was diagnosed IBD before colonoscopy * Pregnant woman * A patient who cannot maintain sedation level because of significant cardiovascular disease, renal disease, pulmonary disease * A patient who do not agree to participate in this study * A patient who cannot understand this study because of foreigner or retarded mental status * A patient who have lower body weight, less than 37.5kg

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction of subjects1 week later after colonoscopyFrom previously reports, both pethidine and fentanyl are safe and effective agents for sedative colonoscopy. Therefore, we will check the subjects' satisfaction of procedure. If patients' satisfaction of procedure under one drug comparing to the others, we will select one drug as pain killer during colonoscopy.

Countries

South Korea

Contacts

Primary ContactSung Pil Hong, MD
sphong@yuhs.ac82-2-2228-1988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026