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

Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072435

Enrollment

Registered

2010-02-22

Start date

2010-03-31

Completion date

2010-11-30

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

Keywords

ERCP, patient-controlled sedation, target-controlled infusion, propofol, Sedation with propofol for ERCP, Endoscopic Retrograde Cholangiopancreatography

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 .

Interventions

DEVICEPatient-controlled sedation

Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.

DEVICETarget-controlled infusion

Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* elective ERCP patients

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026