Methadone Pharmacokinetics in End-stage Renal Disease
Postoperative Pharmacokinetics of Methadone in Patients With Chronic Kidney Disease
Pontificia Universidad Catolica de Chile
20 participants
Apr 5, 2024
OBSERVATIONAL
Conditions
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 After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it.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
Inclusion Criteria4
- 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 Criteria10
- 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
Interventions
* Explanation of the surgery and use of the IV-PCA pump. * Signed informed consent.
Bolus of methadone 0.1mg/kg based on ideal body weight (up to a maximum dose of 20 mg), at the beginning of surgery.
Installation of IV-PCA of methadone. Program to be used with no background infusion, boluses of 1 mg, and the intervals between boluses of 8 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06056245