NCT04686058

Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy

Completed Phase 3 Last updated 24 December 2020

What this trial tests

Phase 3 trial testing Propofol 10 MG/ML Injection in Colonoscopy in 105 participants. Completed in 1 December 2014.

Timeline

1 March 2014

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Universiti Kebangsaan Malaysia Medical Centre
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	105
Start date	1 March 2014
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across Malaysia

Drugs / interventions tested

• Propofol 10 MG/ML Injection
• Midazolam injection — full drug profile →
• Pethidine Hydrochloride 50 Mg/mL Solution for Injection — full drug profile →
• target controlled infusion pump
• patient-controlled sedation pump

Conditions studied

• Colonoscopy — all drugs for Colonoscopy →

Sponsor

Universiti Kebangsaan Malaysia Medical Centre — full company profile →

Who can join

Adults 18 to 80, any sex, with Colonoscopy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)
  Time frame: From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery
  Recovery of patient from sedation when MOAAS 5 is achieved
• Recovery time to ambulation
  Time frame: From time of arrival at the recovery area after completion of colonoscopy, until the point patient starts to ambulate, assessed up to 2 hours post arrival at recovery
  Recovery of patient from sedation when patient starts ambulating
• Recovery time to discharge
  Time frame: From time of arrival at the recovery area after completion of colonoscopy, until the point patient is deemed fit for discharge home, assessed up to 2 hours post arrival at recovery
  Recovery of patient from sedation when patient is deemed fit for discharge home
• Endoscopist satisfaction score
  Time frame: After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy
  After completion of colonoscopy, the endoscopist graded on a scale of 1 to 10, ease of the colonoscopy/procedure (1 = very difficult, 10 = very easy), and level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
• Patient satisfaction score
  Time frame: Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation
  After completion of colonoscopy, the patient graded on a scale of 1 to 10, the level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
• Patient willingness to repeat the same sedation technique
  Time frame: From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery
  Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future

Sponsor's own description

This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.