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Recruiting NCT06056245

Methadone Pharmacokinetics in End-stage Renal Disease

Trial Parameters

Condition Chronic Kidney Diseases
Sponsor Pontificia Universidad Catolica de Chile
Study Type OBSERVATIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-05
Completion 2024-12-31
Interventions
Preoperative stepIntraoperativePost-operative

Brief Summary

The goal of this observational study is to describe the influence of renal function on the pharmacokinetics of methadone used through an intravenous patient-controlled analgesia (IV-PCA) pump for the management of acute postoperative pain. After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it. The main question the study aims to answer is: • Is the pharmacokinetic of methadone used in an IV-PCA pump impaired in patients with chronic kidney disease?

Eligibility Criteria

Inclusion Criteria: * Patients with chronic kidney disease (CrCl 15-60 ml/min) * Patients over 18 years old undergoing surgery requiring general anesthesia with subsequent use of intravenous methadone patient-controlled analgesia * Hospital stay ≥ 48 hours * Body mass index 18-35 kg/m2 Exclusion Criteria: * History of liver disease * Need for dialysis (hemo or peritoneal dialysis) * Use of home oxygen therapy * American Society of Anesthesiologists (ASA) physical status IV-V * Pregnancy * Chronic opioid use * Methadone allergy * Prolonged QT interval * Use of antiarrhythmics that prolong the QT interval * Inability to understand the proper use of PCA

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