Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Phase 4

Completed

• Conditions: Sedation
• Interventions: Device: Patient-controlled sedation; Device: Target-controlled infusion

• Registration Number: NCT01072435
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).

Detailed Description

80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .

Study Timeline

• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Study Start: 2010-03
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• elective ERCP patients

Exclusion Criteria

• allergy to propofol or opioid;
• inability to cooperate;
• ASA(American Society of Anaesthesiology)class greater than 3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient-controlled sedation	Patient-controlled sedation	PCS
target-controlled infusion	Target-controlled infusion	TCI

Primary Outcome Measures

Name	Time	Method
patient's and endoscopist´s satisfaction,	One day
vital signs:oxygen saturation,blood pressure,heart rate,breathing rate	One day
sedation degrees	One day
propofol consumption	One day

Trial Locations

Locations (1)

Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit; 🇫🇮 Helsinki, Uusimaa, Finland