Sedation Techniques for Outpatient Colonoscopy

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686058
• Other study ID #: FF-2014-203
• Status: Completed
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2020
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Propofol 10 MG/ML Injection

• Midazolam injection

• Pethidine Hydrochloride 50 Mg/mL Solution for Injection

Device:
• target controlled infusion pump

• patient-controlled sedation pump

Locations

Country	Name	City	State
Malaysia	Pusat Perubatan Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time taken to onset of sedation	Time taken for patient to reach a sedation score of MOAAS 3 or 4	From start of sedation until MOAAS 3 or 4 attained, assessed up to one hour from the point sedation was commenced
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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