Clinical trial

Postoperative Pharmacokinetics of Methadone in Patients With Chronic Kidney Disease

Name

230125010

Description

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 After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it.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?

Trial arms

Trial start

2024-04-05

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Recruiting

Treatment

Preoperative step

* Explanation of the surgery and use of the IV-PCA pump. * Signed informed consent.

Arms:

Study group

Intraoperative

Bolus of methadone 0.1mg/kg based on ideal body weight (up to a maximum dose of 20 mg), at the beginning of surgery.

Arms:

Study group

Other names:

Methadone administration during surgery

Post-operative

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.

Arms:

Study group

Other names:

Methadone boluses administered by IV-PCA pump

Size

Primary endpoint

Plasma concentration

5, 15, 30, 60 minutes and 2, 4, 6, 9, 12, 24, 36 and 72 hours after the intraoperative bolus of methadone

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-10

1 organization

2 products

4 indications

Organization

Pontificia Universidad Catolica de Chile

Product

Intraoperative

Indication

Chronic Kidney Disease

Indication

Indication

Indication

Product