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Completed

NCT Number: NCT04686058

Sedation Techniques for Outpatient Colonoscopy

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

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Key information

Conditions

Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pusat Perubatan Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol 10 MG/ML Injection

Drug

Other names: propofol

Midazolam injection

Drug

Other names: midazolam

Pethidine Hydrochloride 50 Mg/mL Solution for Injection

Drug

Other names: pethidine

target controlled infusion pump

Device

Other names: TCI

patient-controlled sedation pump

Device

Other names: PCS

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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).

  5. 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).

  6. 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

  1. Rescue analgesic drug requirement

    Time frame: From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation

    Requirement for rescue analgesic or sedative in addition to study drugs/sedatives, during the entire duration of colonoscopy

  2. Total drug consumption

    Time frame: 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

    Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy

  3. Ease of colonoscopy score

    Time frame: during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy

    endoscopist graded on a scale of 1 to 10, ease of procedure (1 = very difficult, 10 = very easy)

  4. Recalled events during colonoscopy

    Time frame: Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery

    The number of recalled events during the entire duration of colonoscopy

  5. Recalled discomfort/ pain during colonoscopy

    Time frame: 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

    The number of recalled events of discomfor/pain during the entire duration of colonoscopy

Other outcomes

  1. Time taken to onset of sedation

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

    Time taken for patient to reach a sedation score of MOAAS 3 or 4

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 28, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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