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

Study Overview
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Brief Summary
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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
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Health Check up Colonoscopy

Intervention / Treatment
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* Drug: fentanyl doses
* Drug: pethidine dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl arm<br>The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and fentanyl. | Drug: fentanyl doses<br>* 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)<br>|
| Active Comparator: Pethidine arm<br>The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and pethidine. | Drug: pethidine dose<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of subjects | 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. | 1 week later after colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, sedation, propofol, fentanyl, pethidine