Sedation Techniques for Outpatient Colonoscopy

Study Overview
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TCI propofol<br>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<br> <br> * Other names: propofol;Device: target controlled infusion pump<br> <br> * Other names: TCI;|
| Active Comparator: PCS propofol<br>Patient-controlled sedation titrated by the patient to comfort level | Drug: Propofol 10 MG/ML Injection<br> <br> * Other names: propofol;Device: patient-controlled sedation pump<br> <br> * Other names: PCS;|
| Active Comparator: midazolam and pethidine<br>Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation | Drug: Midazolam injection<br> <br> * Other names: midazolam;Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection<br> <br> * Other names: pethidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue analgesic drug requirement | Requirement for rescue analgesic or sedative in addition to study drugs/sedatives, during the entire duration of colonoscopy | 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 | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TCI propofol, PCS propofol, sedation, colonoscopy