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

Norwegian University of Science and Technology

Status and phase

Completed

Phase 4

Conditions

Hypothermia

Treatments

Drug: fentanyl and midazolam

Drug: remifentanil and propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT00667043

OPI 07 001

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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