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

NCT ID: NCT01072435

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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 .

Conditions

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Sedation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patient-controlled sedation

PCS

Group Type ACTIVE_COMPARATOR

Patient-controlled sedation

Intervention Type DEVICE

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.

target-controlled infusion

TCI

Group Type ACTIVE_COMPARATOR

Target-controlled infusion

Intervention Type DEVICE

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

Interventions

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Patient-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.

Intervention Type DEVICE

Target-controlled infusion

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

Intervention Type DEVICE

Other Intervention Names

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Arcomed/Syramed AG infusion pump designed for self administration of medicines Arcomed/Syramed AG target-controlled infusion device.

Eligibility Criteria

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Inclusion Criteria

* elective ERCP patients

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maxim Mazanikov

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maxim Mazanikov, MD

Role: PRINCIPAL_INVESTIGATOR

Helsiki University Central Hospital,Department of Anaesthesiology

Marianne Udd, MD.,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Leena Kylänpää, Docent

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Outi Lindström, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Jorma Halttunen, Docent

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Martti Färkilä, Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastroenterology

Reino Pöyhiä, Docent

Role: STUDY_CHAIR

Helsinki University Central Hospital,Department of Anaesthesiology

Harri Mustonen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland

Locations

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Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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2009-015564-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

a005c

Identifier Type: -

Identifier Source: org_study_id