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Clinical Trials/EUCTR2013-000201-23-NL
EUCTR2013-000201-23-NL
Active, not recruiting
Not Applicable

A randomised clinical trial evaluating the effect of remifentanil vs fentanylduring cardiac surgery on the incidence of chronic thoracic pain. - REFLECT

St. Antonius Ziekenhuis0 sitesMay 30, 2013
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DrugsRemifentanil HCL 2 mg vialFentanyl 100 ug = 2 ml vialFentanyl 500 ug = 10 ml vial

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
St. Antonius Ziekenhuis
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 30, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •All patients living in Utrecht and surroundings undergoing cardiac surgery via sternotomy, including a CABG and/or valve replacement, admitted to the ICU or PACU in the St. Antonius hospital, between 18 and 85 years old, weighing between 45 and 140 kg, written informed consent.
  • •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 63
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 63

Exclusion Criteria

  • •\- Pregnancy/ breastfeeding
  • •\- Language barrier
  • •\- History of drug abuse
  • •\- Neurologic condition such as peripheral neuropathy
  • •\- Known morphine or paracetamol allergy
  • •\- BMI \> 35 kg/m2

Outcomes

Primary Outcomes

Not specified

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