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

North District Hospital

Status: Completed

Conditions: Colonoscopy

Treatments: Drug: Propofol and Alfentanil; Drug: diazemuls, pethidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00566683

CRE-2005.010-T

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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194 participants in 2 patient groups

1

Active Comparator group

Description:

Diazemuls-Pethidine

Treatment:

Drug: diazemuls, pethidine

2

Active Comparator group

Description:

Propofol- Alfentanil

Treatment:

Drug: Propofol and Alfentanil