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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborator: St. Olavs Hospital
• Treatments: Fentanyl; Midazolam; Propofol; Remifentanil

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