CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Methadonedrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05075265
NCT05075265N/ACompleted

Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation

Pontificia Universidad Catolica de Chile·observational·Posted Oct 12, 2021·Updated May 31, 2025

In Brief

An observational study evaluating Methadone for Cardiosurgery and 2 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 12, 2021
Enrollment StartOct 2, 2021
Primary CompletionDec 31, 2022
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.7 years ago

Interventions

Methadonedrug

Standard dose of 0.2 ug/kg before Cardiopulmonary Bypass.