Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maxim Mazanikov, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01079312
First received: March 1, 2010
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.


Condition Intervention Phase
Endoscopic Retrograde Cholangiopancreatography
Device: infusion pump
Device: infusion pump for patient-controlled sedation
Drug: propofol
Drug: fentanyl
Drug: sedative mixture
Drug: remifentanil hydrochlorid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • propofol and opioid consumption [ Time Frame: one day ] [ Designated as safety issue: No ]
    total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure

  • vital signs [ Time Frame: one day ] [ Designated as safety issue: Yes ]
    heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration

  • patient´s and endoscopist´s satisfaction [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sedation level [ Time Frame: one day ] [ Designated as safety issue: No ]
    sedation level assested with Ramsay,Gillham,OAA/S sedation scores


Enrollment: 80
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol infusion
Anaesthesiologist`s managed intravenous infusion of propofol 10mg/ml
Device: infusion pump
anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level
Other Names:
  • -Braun AG
  • -an infusion pump
Drug: propofol
Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.
Other Names:
  • -Diprivan
  • -Recofol
  • -Fresofol
Drug: fentanyl
Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.
Other Names:
  • -fentanyl citrate
  • -fentanyl
Active Comparator: Patient-controlled sedation
self-administration of propofol and remifentanil mixture during ERCP
Device: infusion pump for patient-controlled sedation
self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.
Other Names:
  • -Arcomed,Syramed AG,Switzerland
  • -infusion pump designed for self administration of the drugs
Drug: propofol
Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.
Other Names:
  • -Diprivan
  • -Recofol
  • -Fresofol
Drug: sedative mixture
Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)
Other Names:
  • -Ultiva
  • -Diprivan
Drug: remifentanil hydrochlorid
Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)
Other Name: -Ultiva

Detailed Description:

80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective ERCP-patients

Exclusion Criteria:

  • allergy to propofol or opioid;
  • ASA-class (American Society of Anaesthesiology) greater than 3;
  • inability to co-operate;
  • drugs abuse.
  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: NCT01079312

Locations
Finland
Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Maxim Mazanikov, MD Helsinki University Central Hospital,Department of Anaesthesiology
Principal Investigator: Marianne Udd, MD, PhD Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Outi Lindström, MD Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Leena Kylänpää, Docent Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Pekka Aho, MD, PhD Helsinki University Central Hospital,Department of Vascular Surgery
Principal Investigator: Jorma Halttunen, Docent Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Martti Färkilä, Professor Helsinki University Central Hospital,Department of Gasroenterology
Study Chair: Reino Pöyhiä, Docent Helsinki University Central Hospital,Department of Anaesthesiology
  More Information

No publications provided by Helsinki University Central Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maxim Mazanikov, M.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01079312     History of Changes
Other Study ID Numbers: a001c, 2008-007968-42
Study First Received: March 1, 2010
Last Updated: July 4, 2012
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
ERCP
patient-controlled sedation
propofol
remifentanil
sedation level

Additional relevant MeSH terms:
Propofol
Remifentanil
Hypnotics and Sedatives
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on September 15, 2014