Status:

RECRUITING

Methadone Pharmacokinetics in End-stage Renal Disease

Lead Sponsor:

Pontificia Universidad Catolica de Chile

Conditions:

Chronic Kidney Diseases

Post Operative Pain

Eligibility:

All Genders

18+ years

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 ...

Detailed Description

This study will be carried out at the Pontifical Catholic University of Chile Hospital with prior approval by the ethics committee. Study staff will assess the inclusion criteria, obtain informed cons...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 5 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06056245

Start Date

April 5 2024

End Date

December 31 2024

Last Update

May 10 2024

Active Locations (1)

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Pontificia Universidad Católica de Chile

Santiago, Chile, 7550000