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NCT00566683 Clinical Trial

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

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00566683
Other study ID # CRE-2005.010-T
Secondary ID
Status Completed
Phase N/A
First received November 30, 2007
Last updated November 30, 2007
Start date July 2005
Est. completion date June 2006

Study information
Verified date November 2007
Source North District Hospital
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 194
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
North District Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Pain after recovery No
Secondary sedation thorughout the procedure No
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