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

Not Applicable

• Conditions: Health Check up Colonoscopy
• Interventions: Drug: fentanyl doses; Drug: pethidine dose

• Registration Number: NCT02039453
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-09
• Status Verified: 2014-01
• Study First Submitted: 2014-01-12
• Study First Submitted QC: 2014-01-15
• Last Update Submitted: 2014-01-15
• Study First Posted: 2014-01-17
• Last Update Posted: 2014-01-17
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl arm	fentanyl doses	The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and fentanyl.
Pethidine arm	pethidine dose	The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and pethidine.

Primary Outcome Measures

Name	Time	Method
Satisfaction of subjects	1 week later after colonoscopy	From 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.

Trial Locations

Locations (1)

Division of Gastroenterology Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of