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Clinical Trials/NCT00566683
NCT00566683
Completed
Not Applicable

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

North District Hospital0 sites194 target enrollmentJuly 2005

Overview

Phase
Not Applicable
Intervention
diazemuls, pethidine
Conditions
Colonoscopy
Sponsor
North District Hospital
Enrollment
194
Primary Endpoint
Pain
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2005
End Date
June 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
North District Hospital

Eligibility Criteria

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

Arms & Interventions

1

Diazemuls-Pethidine

Intervention: diazemuls, pethidine

2

Propofol- Alfentanil

Intervention: Propofol and Alfentanil

Outcomes

Primary Outcomes

Pain

Time Frame: after recovery

Secondary Outcomes

  • sedation(thorughout the procedure)

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