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Methadone in Adults Undergoing Cardiac Surgery

NCT05075265 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2025-05-31

No results posted yet for this study

Summary

In cardiac surgery, the establishment of Cardiopulmonary bypass (CPB) involves profound changes that can alter the pharmacokinetics and clinical response to drugs. Methadone has characteristics that make it attractive for the management of postoperative pain, however, to date there are no pharmacokinetic or pharmacodynamic studies that allow guidance on how to perform the dosage and dose adjustment of methadone in patients undergoing cardiopulmonary bypass.

The main of this study is to describe the pharmacokinetics of methadone in adult patients undergoing cardiac surgery with extracorporeal circulation.

A pharmacokinetic clinical study will be proposed. Drug concentrations will be measured at different times, estimating how plasma levels vary before, during and after CPB. For the plasma methadone analysis, 10 blood samples will be taken from each patient following a pre-established schedule. They will be analyzed using a high performance liquid chromatography (HPLC) spectrofluorometric method.

Changes in volumes, clearance, and other covariates associated with CPB are not expected to significantly affect methadone plasma concentrations.

Conditions

  • Cardiosurgery
  • Cardiopulmonary Bypass
  • Methadone

Interventions

DRUG

Methadone

Standard dose of 0.2 ug/kg before Cardiopulmonary Bypass.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Wilbaldo Salas, MD · Pontificia Universidad Catolica de Chile

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-02
Primary Completion
2022-12-31
Completion
2023-06-01

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05075265 on ClinicalTrials.gov