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

Official Title: “Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial”

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Study group 1
  • Midazolam and fentanyl; continuous intravenous infusions
• Active Comparator: Study group 2
  • Propofol and remifentanil; continuous intravenous infusion

Primary 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Norwegian University of Science and Technology Other

Overall Clinical Trial Officials and Contacts

Pål Klepstad, MD, PhD Study Director NTNU  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00667043

Study ID Number: OPI 07 001

ClinicalTrials.gov Identifier: NCT00667043

Health Authority: Norway: Data Inspectorate