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

This study has been completed.
Sponsor:
Information provided by:
North District Hospital
ClinicalTrials.gov Identifier:
NCT00566683
First received: November 30, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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
Colonoscopy
Drug: diazemuls, pethidine
Drug: Propofol and Alfentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sedation [ Time Frame: thorughout the procedure ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: July 2005
Study Completion Date: June 2006
Arms Assigned Interventions
Active Comparator: 1
Diazemuls-Pethidine
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566683

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

No publications provided

Responsible Party: Poon Chi-Ming, North District Hospital
ClinicalTrials.gov Identifier: NCT00566683     History of Changes
Other Study ID Numbers: CRE-2005.010-T
Study First Received: November 30, 2007
Last Updated: November 30, 2007
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

Additional relevant MeSH terms:
Alfentanil
Meperidine
Diazepam
Propofol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 24, 2014