Sedation Techniques for Outpatient Colonoscopy

Universiti Kebangsaan Malaysia Medical Centre105 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

105

Conditions

Colonoscopy

Interventions

Propofol 10 MG/ML InjectionDRUG

Midazolam injectionDRUG

Pethidine Hydrochloride 50 Mg/mL Solution for InjectionDRUG

target controlled infusion pump

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)

Recovery of patient from sedation when MOAAS 5 is achieved

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 time to ambulation

Recovery of patient from sedation when patient starts ambulating

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 time to discharge

Recovery of patient from sedation when patient is deemed fit for discharge home

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

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).

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

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).

Time frame: 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

Data from ClinicalTrials.gov

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Secondary Outcomes

Rescue analgesic drug requirement

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

Time frame: 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

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

Ease of colonoscopy score

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

Time frame: 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

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

Recalled discomfort/ pain during colonoscopy

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