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| Sponsor: | North District Hospital |
|---|---|
| Information provided by: | North District Hospital |
| ClinicalTrials.gov Identifier: | NCT00566683 |
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 |
| 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
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|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| 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 |
|
Propofol colonoscopy sedation pain compare NAPS versus diazemuls in outpatient colonoscopy |
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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 |
