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Sedation Techniques for Outpatient Colonoscopy

NCT ID: NCT04686058

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Colonoscopy

Keywords

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TCI propofol PCS propofol sedation colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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TCI propofol

Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale

Group Type ACTIVE_COMPARATOR

Propofol 10 MG/ML Injection

Intervention Type DRUG

target controlled infusion pump

Intervention Type DEVICE

PCS propofol

Patient-controlled sedation titrated by the patient to comfort level

Group Type ACTIVE_COMPARATOR

Propofol 10 MG/ML Injection

Intervention Type DRUG

patient-controlled sedation pump

Intervention Type DEVICE

midazolam and pethidine

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

Group Type ACTIVE_COMPARATOR

Midazolam injection

Intervention Type DRUG

Pethidine Hydrochloride 50 Mg/mL Solution for Injection

Intervention Type DRUG

Interventions

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Propofol 10 MG/ML Injection

Intervention Type DRUG

Midazolam injection

Intervention Type DRUG

Pethidine Hydrochloride 50 Mg/mL Solution for Injection

Intervention Type DRUG

target controlled infusion pump

Intervention Type DEVICE

patient-controlled sedation pump

Intervention Type DEVICE

Other Intervention Names

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propofol midazolam pethidine TCI PCS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Nadia Md Nor

Primary Investigator, consultant anaesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pusat Perubatan Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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FF-2014-203

Identifier Type: -

Identifier Source: org_study_id