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

Primary Purpose

Hypothermia

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
remifentanil and propofol
fentanyl and midazolam
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypothermia focused on measuring therapeutic hypothermia, cardiac arrest, sedation, remifentanil, propofol, fentanyl, midazolam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stavanger University Hospital
  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study group 1

Study group 2

Arm Description

Midazolam and fentanyl; continuous intravenous infusions

Propofol and remifentanil; continuous intravenous infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2008
Last Updated
April 25, 2012
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00667043
Brief Title
Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Acronym
Cool Sedation
Official Title
Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
therapeutic hypothermia, cardiac arrest, sedation, remifentanil, propofol, fentanyl, midazolam

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group 1
Arm Type
Active Comparator
Arm Description
Midazolam and fentanyl; continuous intravenous infusions
Arm Title
Study group 2
Arm Type
Active Comparator
Arm Description
Propofol and remifentanil; continuous intravenous infusion
Intervention Type
Drug
Intervention Name(s)
remifentanil and propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
fentanyl and midazolam
Intervention Description
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pål Klepstad, MD, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Director
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4068
Country
Norway
Facility Name
St. Olavs Hospital
City
Trondheim
State/Province
Sør-Trøndelag
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22527063
Citation
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.
Results Reference
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Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial

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