Sedation Techniques for Outpatient Colonoscopy

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

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Propofol 10 MG/ML Injection; Device: target controlled infusion pump; Device: patient-controlled sedation pump; Drug: Midazolam injection; Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Pusat Perubatan Universiti Kebangsaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TCI propofol; Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale	Drug: Propofol 10 MG/ML Injection; Other Names: propofol; Device: target controlled infusion pump; Other Names: TCI
Active Comparator: PCS propofol; Patient-controlled sedation titrated by the patient to comfort level	Drug: Propofol 10 MG/ML Injection; Other Names: propofol; Device: patient-controlled sedation pump; Other Names: PCS
Active Comparator: midazolam and pethidine; Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation	Drug: Midazolam injection; Other Names: midazolam; Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection; Other Names: pethidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)	Recovery of patient from sedation when MOAAS 5 is achieved	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 time to ambulation	Recovery of patient from sedation when patient starts ambulating	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 time to discharge	Recovery of patient from sedation when patient is deemed fit for discharge home	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
Endoscopist satisfaction score	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).	After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy
Patient satisfaction score	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 satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation
Patient willingness to repeat the same sedation technique	Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future	From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue analgesic drug requirement	Requirement for rescue analgesic or sedative in addition to study drugs/sedatives, during the entire duration of colonoscopy	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	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	endoscopist graded on a scale of 1 to 10, ease of procedure (1 = very difficult, 10 = very easy)	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	The number of recalled events during the entire duration of 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	The number of recalled events of discomfor/pain during the entire duration of 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken to onset of sedation	Time taken for patient to reach a sedation score of MOAAS 3 or 4	From start of sedation until MOAAS 3 or 4 attained, assessed up to one hour from the point sedation was commenced

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: colonoscopy; sedation; TCI propofol; PCS propofol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Propofol; Meperidine
• Other Study ID Numbers: FF-2014-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No