Sedation Techniques for Outpatient Colonoscopy

NCT04686058 | Completed Phase 3 DMC

• 1 other identifier: FF-2014-203
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonoscopy

Keywords

TCI propofol; PCS propofol; sedation; colonoscopy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

Other Outcomes (1)

• Time taken to onset of sedation

  From start of sedation until MOAAS 3 or 4 attained, assessed up to one hour from the point sedation was commenced

Study Arms (3)

TCI propofol

ACTIVE COMPARATOR

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; Device: target controlled infusion pump

PCS propofol

ACTIVE COMPARATOR

Patient-controlled sedation titrated by the patient to comfort level

Drug: Propofol 10 MG/ML Injection; Device: patient-controlled sedation pump

midazolam and pethidine

ACTIVE COMPARATOR

Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation

Drug: Midazolam injection; Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection

Interventions

Propofol 10 MG/ML Injection DRUG

Also known as: propofol

PCS propofol; TCI propofol

Midazolam injection DRUG

Also known as: midazolam

midazolam and pethidine

Pethidine Hydrochloride 50 Mg/mL Solution for Injection DRUG

Also known as: pethidine

midazolam and pethidine

target controlled infusion pump DEVICE

Also known as: TCI

TCI propofol

patient-controlled sedation pump DEVICE

Also known as: PCS

PCS propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Interventions

Propofol; Injections; Midazolam; Meperidine; Solutions

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator, consultant anaesthesiologist

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 28, 2020
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)