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Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial (Cool Sedation)

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00667043
First received: April 23, 2008
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.


Condition Intervention Phase
Hypothermia
 Drug: remifentanil and propofol
Drug: fentanyl and midazolam
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam. [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study group 1
Midazolam and fentanyl; continuous intravenous infusions
 Drug: fentanyl and midazolam
Patients will receive: midazolam; continuous intravenous infusion, concentration 5 mg/ml, 2-10 mg/hour and fentanyl; continuous intravenous infusion, concentration 0,050 mg/ml, 0.025-0.5 mg/hour. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.
Active Comparator: Study group 2
Propofol and remifentanil; continuous intravenous infusion
 Drug: remifentanil and propofol
Patients will receive: propofol, continuous intravenous infusion, concentration 10 mg/ml, 1-4 mg/kg/hour and remifentanil; continuous intravenous infusion 0,050 mg/ml, 0.1-0.3 microgram/kg/min. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
  • Patients must be 18 years or older
  • Inclusion must be approved by the attending physician

Exclusion Criteria:

  • Pregnant women
  • Cardiovascular unstable patients in a deteriorating circulatory status which require multiple other therapeutic measures that makes participation practically impossible
  • Liver or renal failure defined as sequential organ failure assessment (SOFA)-score 3 or 4
  • History of drug allergies, or contraindications for the study drugs
  • Patients using a scheduled dose of any of the study drugs.
  • Patients with a known substance abuse of opioids or benzodiazepines
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667043

Locations
Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4068
St. Olavs Hospital
Trondheim, Sør-Trøndelag, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Pål Klepstad, MD, PhD NTNU
  More Information

Publications:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00667043     History of Changes
Other Study ID Numbers: OPI 07 001
Study First Received: April 23, 2008
Last Updated: April 25, 2012
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Institute of Public Health
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
therapeutic hypothermia
cardiac arrest
sedation
remifentanil
 propofol
fentanyl
midazolam

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Midazolam
Fentanyl
Propofol
Remifentanil
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013