Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Information source: Norwegian University of Science and Technology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypothermia
Intervention: remifentanil and propofol (Drug); fentanyl and midazolam (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Norwegian University of Science and Technology Official(s) and/or principal investigator(s):
Pål Klepstad, MD, PhD, Study Director, Affiliation: NTNU
Summary
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.
Clinical Details
Official title: Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Stavanger University Hospital, Stavanger, Rogaland 4068, Norway
St. Olavs Hospital, Trondheim, Sør-Trøndelag 7006, Norway
Additional Information
Starting date: April 2008
Last updated: April 25, 2012
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