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

Hypothermia Clinical Trial

— Cool Sedation  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667043
• Other study ID #: OPI 07 001
• Status: Completed
• Phase: Phase 4
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger	Rogaland
Norway	St. Olavs Hospital	Trondheim	Sør-Trøndelag

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Bjelland TW, Dale O, Kaisen K, Haugen BO, Lydersen S, Strand K, Klepstad P. Propofol and remifentanil versus midazolam and fentanyl for sedation during therapeutic hypothermia after cardiac arrest: a randomised trial. Intensive Care Med. 2012 Jun;38(6):95 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2010