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

NCT00667043 | Completed Phase 4

• 1 other identifier: OPI 07 001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypothermia

Keywords

therapeutic hypothermia; cardiac arrest; sedation; remifentanil; propofol; fentanyl; midazolam

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study group 1

ACTIVE COMPARATOR

Midazolam and fentanyl; continuous intravenous infusions

Drug: fentanyl and midazolam

Study group 2

ACTIVE COMPARATOR

Propofol and remifentanil; continuous intravenous infusion

Drug: remifentanil and propofol

Interventions

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.

Study group 2

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.

Study group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
• Patients must be 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (2)

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

Location

St. Olavs Hospital

Trondheim, Sør-Trøndelag, 7006, Norway

Location

Related 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):959-67. doi: 10.1007/s00134-012-2540-1. Epub 2012 Apr 12.

  PMID: 22527063 RESULT

MeSH Terms

Conditions

Hypothermia; Heart Arrest

Interventions

Remifentanil; Propofol; Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pål Klepstad, MD, PhD

  National Taiwan Normal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2010
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

NO (2)