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Comparison Between Nurse-Administered Propofol Sedation and Diazemuls / Pethidine in Outpatient Colonoscopy

NCT ID: NCT00566683

Last Updated: 2007-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-06-30

Brief Summary

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Colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology. Different modalities of pain control have been described in the past. Propofol is a perfect drug for endoscopic procedure since it has the characteristic of fast onset, short half-life and early recovery. Its unfamiliarity and its potential cardiovascular and respiratory side effect make it unpopular to endoscopists. Recent reports showed propofol is safe in bolus titration by nurse in Caucasian in all endoscopic procedures. Our previous pilot study showed nurse administered propofol sedation (NAPS) is effective and safe and highly acceptable by Chinese patients. Here we conduct a randomized controlled study to compare the effectiveness of NAPS versus traditional sedation.

Detailed Description

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Conditions

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Colonoscopy

Keywords

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Propofol colonoscopy sedation pain compare NAPS versus diazemuls in outpatient colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Diazemuls-Pethidine

Group Type ACTIVE_COMPARATOR

diazemuls, pethidine

Intervention Type DRUG

5mg Diazemuls and 25mg Pethidine one min. before procedure followed by bolus doses of 2.5mg Diazemuls / 12.5mg Pethidine at the discretion of endoscopists Maximal dose of 0.2mg/kg Diazemuls and 1mg/kg Pethidine

2

Propofol- Alfentanil

Group Type ACTIVE_COMPARATOR

Propofol and Alfentanil

Intervention Type DRUG

Loading dose of 40-60mg or 0.8mg/kg Propofol one min. before procedure Propofol 200mg + Alfentanil 0.5mg, 1.5ml per bolus (bolus dose of 14.3mg Propofol + 35ug Alfentanil) via PCA pump No maximal dose Zero lockout time

Interventions

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diazemuls, pethidine

5mg Diazemuls and 25mg Pethidine one min. before procedure followed by bolus doses of 2.5mg Diazemuls / 12.5mg Pethidine at the discretion of endoscopists Maximal dose of 0.2mg/kg Diazemuls and 1mg/kg Pethidine

Intervention Type DRUG

Propofol and Alfentanil

Loading dose of 40-60mg or 0.8mg/kg Propofol one min. before procedure Propofol 200mg + Alfentanil 0.5mg, 1.5ml per bolus (bolus dose of 14.3mg Propofol + 35ug Alfentanil) via PCA pump No maximal dose Zero lockout time

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-65 undergoing elective outpatient colonoscopy

Exclusion Criteria

* American Society of Anesthesiologist Class III or above
* History of difficult endotracheal intubation
* Known allergy to propofol, eggs or soy products, opioid, benzodiazepines
* previous colectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North District Hospital

OTHER

Sponsor Role lead

Responsible Party

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North District Hospital

Principal Investigators

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Chi-Ming Poon, MBBS

Role: PRINCIPAL_INVESTIGATOR

North District Hospital

Other Identifiers

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CRE-2005.010-T

Identifier Type: -

Identifier Source: org_study_id