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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maxim Mazanikov, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01072435
First received: February 19, 2010
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Sedation
Device: Patient-controlled sedation
Device: Target-controlled infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • sedation degrees [ Time Frame: One day ] [ Designated as safety issue: Yes ]
  • patient`s and endoscopist´s satisfaction, [ Time Frame: One day ] [ Designated as safety issue: Yes ]
  • propofol consumption [ Time Frame: One day ] [ Designated as safety issue: Yes ]
  • vital signs:oxygen saturation,blood pressure,heart rate,breathing rate [ Time Frame: One day ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: patient-controlled sedation
PCS
Device: 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.
Other Name: Arcomed/Syramed AG infusion pump designed for self administration of medicines
Active Comparator: target-controlled infusion
TCI
Device: Target-controlled infusion
Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol
Other Name: Arcomed/Syramed AG target-controlled infusion device.

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective ERCP patients

Exclusion Criteria:

  • allergy to propofol or opioid;
  • inability to cooperate;
  • ASA(American Society of Anaesthesiology)class greater than 3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072435

Locations
Finland
Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: 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
Study Chair: Reino Pöyhiä, Docent Helsinki University Central Hospital,Department of Anaesthesiology
Principal Investigator: Harri Mustonen, PhD Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland
  More Information

No publications provided

Responsible Party: Maxim Mazanikov, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01072435     History of Changes
Other Study ID Numbers: a005c, 2009-015564-34
Study First Received: February 19, 2010
Last Updated: July 13, 2012
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
ERCP
patient-controlled sedation
target-controlled infusion
propofol
Sedation with propofol for ERCP
Endoscopic Retrograde Cholangiopancreatography

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 26, 2014