Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborator:	St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00667043

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 IV

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

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride Remifentanil hydrochloride Remifentanil Fentanyl Fentanyl Citrate Propofol

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
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

No publications provided

Responsible Party:	Pål Klepstad, 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:	June 11, 2010
Health Authority:	Norway: Data Inspectorate; Norway: Directorate for Health and Social Affairs; Norway: Norwegian Institute of Public Health; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway

Keywords provided by Norwegian University of Science and Technology:

therapeutic hypothermia
cardiac arrest
sedation

remifentanil and propofol
fentanyl and midazolam
Patients treated with therapeutic hypothermia following cardiac arrest

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 February 09, 2012