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

This study has been completed.
Information provided by:
North District Hospital Identifier:
First received: November 30, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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.

Condition Intervention
Drug: diazemuls, pethidine
Drug: Propofol and Alfentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nurse-Administered Propofol Sedation by PCA Pump Versus Diazemuls / Pethidine in Outpatient Colonoscopy: A Randomized Controlled Study

Resource links provided by NLM:

Further study details as provided by North District Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: after recovery ]

Secondary Outcome Measures:
  • sedation [ Time Frame: thorughout the procedure ]

Enrollment: 194
Study Start Date: July 2005
Study Completion Date: June 2006
Arms Assigned Interventions
Active Comparator: 1
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
Active Comparator: 2
Propofol- Alfentanil
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00566683

Sponsors and Collaborators
North District Hospital
Principal Investigator: Chi-Ming Poon, MBBS North District Hospital
  More Information

Responsible Party: Poon Chi-Ming, North District Hospital Identifier: NCT00566683     History of Changes
Other Study ID Numbers: CRE-2005.010-T
Study First Received: November 30, 2007
Last Updated: November 30, 2007

Keywords provided by North District Hospital:
compare NAPS versus diazemuls in outpatient colonoscopy

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Autonomic Agents
Gastrointestinal Agents
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on March 28, 2017