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

NCT01072435 | Completed Phase 4

• 2 other identifiers: a005c2009-015564-34
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Sedation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

patient-controlled sedation

ACTIVE COMPARATOR

PCS

Device: Patient-controlled sedation

target-controlled infusion

ACTIVE COMPARATOR

TCI

Device: Target-controlled infusion

Interventions

Patient-controlled sedation 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.

Also known as: Arcomed/Syramed AG infusion pump designed for self administration of medicines

patient-controlled sedation

Target-controlled infusion DEVICE

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

Also known as: Arcomed/Syramed AG target-controlled infusion device.

target-controlled infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective ERCP patients

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit

Helsinki, Uusimaa, 00029, Finland

Location

Study Officials

• Maxim Mazanikov, MD

  Helsiki University Central Hospital,Department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

• Marianne Udd, MD.,PhD

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Leena Kylänpää, Docent

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Outi Lindström, MD

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Jorma Halttunen, Docent

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Martti Färkilä, Professor

  Helsinki University Central Hospital,Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

• Reino Pöyhiä, Docent

  Helsinki University Central Hospital,Department of Anaesthesiology

  STUDY CHAIR

• Harri Mustonen, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

FI (1)