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Sedation Techniques for Outpatient Colonoscopy

Sponsor
Universiti Kebangsaan Malaysia Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT04686058
Collaborator
(none)
105
Enrollment
1
Location
3
Arms
9
Actual Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Propofol 10 MG/ML Injection
  • Drug: Midazolam injection
  • Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection
  • Device: target controlled infusion pump
  • Device: patient-controlled sedation pump
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS) [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 [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 [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 [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 [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 [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 Outcome Measures

    1. 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]

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

    2. 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]

      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 [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 [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 [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 Outcome Measures

    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]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pusat Perubatan Universiti Kebangsaan Malaysia Cheras Kuala Lumpur Malaysia 56000

    Sponsors and Collaborators

    • Universiti Kebangsaan Malaysia Medical Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nadia Md Nor, Primary Investigator, consultant anaesthesiologist, Universiti Kebangsaan Malaysia Medical Centre
    ClinicalTrials.gov Identifier:
    NCT04686058
    Other Study ID Numbers:
    • FF-2014-203
    First Posted:
    Dec 28, 2020
    Last Update Posted:
    Dec 28, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nadia Md Nor, Primary Investigator, consultant anaesthesiologist, Universiti Kebangsaan Malaysia Medical Centre
    TCI propofol
    PCS propofol
    sedation
    colonoscopy
    Additional relevant MeSH terms:
    Midazolam
    Meperidine
    Propofol

    Study Results

    No Results Posted as of Dec 28, 2020