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CompletedNCT00566683Updated Dec 3, 2007

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

An interventional study of diazemuls, pethidine and Propofol and Alfentanil in Colonoscopy, sponsored by North District Hospital. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-12-03.

Sponsored by North District Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colonoscopy

Keywords

  • Propofol
  • colonoscopy
  • sedation
  • pain
  • compare NAPS versus diazemuls in outpatient colonoscopy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-65 undergoing elective outpatient colonoscopy

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
194 participants (actual)

Study arms

  • Active comparator
    1

    Diazemuls-Pethidine

    Drug: diazemuls, pethidine

  • Active comparator
    2

    Propofol- Alfentanil

    Drug: Propofol and Alfentanil

Interventions

  • Drugdiazemuls, 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

  • DrugPropofol 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

05

What researchers measure

Primary outcomes

  1. Pain

    Time frame: after recovery

Secondary outcomes

  1. sedation

    Time frame: thorughout the procedure

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT00566683
Lead sponsor
North District Hospital
First posted
Dec 3, 2007
Start date
Jul 2005
Completion
Jun 2006
Last update
Dec 3, 2007

Study contacts

Chi-Ming Poon, MBBS
principal investigator · North District Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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