Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy
Overview
- Phase
- Phase 3
- Intervention
- Propofol 10 MG/ML Injection
- Conditions
- Colonoscopy
- Sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Nadia Md Nor
Primary Investigator, consultant anaesthesiologist
Universiti Kebangsaan Malaysia Medical Centre
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
- •with contraindications to the study drugs
Arms & Interventions
TCI propofol
Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale
Intervention: Propofol 10 MG/ML Injection
TCI propofol
Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale
Intervention: target controlled infusion pump
PCS propofol
Patient-controlled sedation titrated by the patient to comfort level
Intervention: Propofol 10 MG/ML Injection
PCS propofol
Patient-controlled sedation titrated by the patient to comfort level
Intervention: patient-controlled sedation pump
midazolam and pethidine
Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation
Intervention: Midazolam injection
midazolam and pethidine
Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation
Intervention: Pethidine Hydrochloride 50 Mg/mL Solution for Injection
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Rescue analgesic drug requirement(From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation)
- Total drug consumption(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)
- Ease of colonoscopy score(during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy)
- Recalled events during colonoscopy(Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery)
- Recalled discomfort/ pain during colonoscopy(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)