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

Tracking Information

First Received Date ^ICMJE

November 30, 2007

Last Updated Date

November 30, 2007

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain [ Time Frame: after recovery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

sedation [ Time Frame: thorughout the procedure ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Nurse-Administered Propofol Sedation by PCA Pump Versus Diazemuls / Pethidine in Outpatient Colonoscopy: A Randomized Controlled Study

Brief Summary

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Colonoscopy

Intervention ^ICMJE

Drug: diazemuls, pethidine
Drug: Propofol and Alfentanil

Study Arms / Comparison Groups

Active Comparator: Diazemuls-Pethidine
Active Comparator: Propofol- Alfentanil

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

194

Completion Date

June 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00566683

Responsible Party

Poon Chi-Ming, North District Hospital

Study ID Numbers ^ICMJE

CRE-2005.010-T

Study Sponsor ^ICMJE

North District Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Chi-Ming Poon, MBBS

North District Hospital

Information Provided By

North District Hospital

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP