Clinical trial

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

Name

OPI 07 001

Description

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.

Trial arms

Trial start

2008-04-01

Estimated PCD

2009-05-01

Trial end

2010-06-01

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Study group 2

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.

Arms:

Study group 1

Size

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-12-29

1 organization

2 products

1 indication

Organization

Norwegian University of Science and Technology

Product

Remifentanil

Indication

Hypothermia

Product

Fentanyl + Midazolam