Effects of hypothermia on the disposition of morphine, fentanyl, midazolam and propofol in intensive care unit patients

Phase 1

• Conditions: Patients treated with therapeutic hypothermia (33-34 °C) and a control group of normothermic patients matched on sex, age and duration of morphine infusion.

• Registration Number: EUCTR2006-001814-34-NO
• Lead Sponsor: The Norwegian University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-12
• Study Completion: 2009-08-31
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Patients treated with therapeutic hypothermia (33-34°C) and a control group of critically ill patients at a normal temperature (36-38°C).
•Controls will be matched on sex, age and duration of morphine infusion.
•Patients must be 18 years or older.
•Receiving continuous analgesia/sedation with morphine and midazolam for at least 12 hours.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant women
•Cardiovascular unstable patients in deteriorating circulating status.
•Renal failure calculated or measured renal clearance to less than 30.
•Clinical significant liver failure.
•Hemoglobin < 11 g/
•Known history of drug abuse (including cocaine, opiates, amphetamines, etc.) and alcoholism
•History of drug allergies for the study drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the pharmacokinetics of morphine and midazolam during therapeutic hypothermia in order to review the current treatment.<br>;Secondary Objective: To retrieve information on the startup-pharmacokinetics of propofol and fentanyl;Primary end point(s): Terminal elimination half-life (t1/2ß) of morphine in hypothermic compared to normothermic patients in the IC