Clinical trial NCT04686058: Sedation Techniques for Outpatient Colonoscopy
Official title: Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Keywords: TCI propofol
PCS propofol
sedation
colonoscopy
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.

Eligibility criteria: Inclusion Criteria:

* ASA I or II patients
* aged between 18 to 80 years
* scheduled for outpatient colonoscopy

Exclusion Criteria:

* history of or with psychiatric disease
* on psychoactive drugs
* mentally or physically unable to use the hand-held device for PCS
* previous complications from anaesthesia or sedation
* potentially difficult airway maintenance
* obstructive sleep apnoea
* pregnant
* with contraindications to the study drugs

Primary outcomes:
measure: Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)
timeFrame: 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
measure: Recovery time to ambulation
timeFrame: 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
measure: Recovery time to discharge
timeFrame: 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
measure: Endoscopist satisfaction score
timeFrame: After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy
measure: Patient satisfaction score
timeFrame: Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation
measure: Patient willingness to repeat the same sedation technique
timeFrame: From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery
Secondary outcomes:
measure: Rescue analgesic drug requirement
timeFrame: From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation
measure: Total drug consumption
timeFrame: Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy, assessed up to 2 hours from the start of sedation
measure: Ease of colonoscopy score
timeFrame: during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy
measure: Recalled events during colonoscopy
timeFrame: Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery
measure: Recalled discomfort/ pain during colonoscopy
timeFrame: Recalled events of discomfort/pain retrived from the patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery
Other outcomes:
measure: Time taken to onset of sedation
timeFrame: From start of sedation until MOAAS 3 or 4 attained, assessed up to one hour from the point sedation was commenced
Locations:
city: Cheras
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
References: