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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypothermia Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stavanger University Hospital, Stavanger, Rogaland, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remifentanil and propofol

Drug

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 midazolam

Drug

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.

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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

St. Olavs Hospital

Registry information

Acronym: Cool Sedation

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Apr 25, 2008
Registry last updated: Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed