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

NCT00566683 | Completed

• 1 other identifier: CRE-2005.010-T
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy

Keywords

Propofol; colonoscopy; sedation; pain; compare NAPS versus diazemuls in outpatient colonoscopy

Outcome Measures

Primary Outcomes (1)

• Pain

  after recovery

Secondary Outcomes (1)

• sedation

  thorughout the procedure

Study Arms (2)

1

ACTIVE COMPARATOR

Diazemuls-Pethidine

Drug: diazemuls, pethidine

2

ACTIVE COMPARATOR

Propofol- Alfentanil

Drug: Propofol and Alfentanil

Interventions

diazemuls, pethidine DRUG

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

1

Propofol and Alfentanil DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 undergoing elective outpatient colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• North District Hospital: lead

MeSH Terms

Conditions

Pain

Interventions

Diazepam; Meperidine; Propofol; Alfentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl

Study Officials

• Chi-Ming Poon, MBBS

  North District Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: July 1, 2005
• Study Completion: June 1, 2006
• Last Updated: December 3, 2007

Record last verified: 2007-11