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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00566683
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : December 3, 2007
Information provided by:
North District Hospital

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: diazemuls, pethidine Drug: Propofol and Alfentanil Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nurse-Administered Propofol Sedation by PCA Pump Versus Diazemuls / Pethidine in Outpatient Colonoscopy: A Randomized Controlled Study
Study Start Date : July 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pain [ Time Frame: after recovery ]

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00566683

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

Responsible Party: Poon Chi-Ming, North District Hospital Identifier: NCT00566683     History of Changes
Other Study ID Numbers: CRE-2005.010-T
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: December 3, 2007
Last Verified: November 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