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

Norwegian University of Science and Technology60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hypothermia

Interventions

remifentanil and propofolDRUG

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.

fentanyl and midazolamDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (2)

Stavanger University Hospital

Stavanger, Rogaland, Norway

St. Olavs Hospital

Trondheim, Sør-Trøndelag, Norway

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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