Methadone in Adults Undergoing Cardiac Surgery

NCT05075265 | Completed DMC

• 1 other identifier: 200323005
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiosurgery; Cardiopulmonary Bypass; Methadone

Keywords

extracorporeal circulation; pharmakinetics

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  Calculate maximum plasma concentration (Cmax) Methadone plasma levels measured with high pressure fluid (HPLC) after a single bolus of Methadone in enrolled adult Adults Undergoing Cardiac Surgery With Extracorporeal Circulation

  Time Frame: 0, 5-10, 30, 60, 120, 240 minutes of operation of the CPB and 12 or 24 hours of CPB]

• Describe the change of the levels of methadone plasmatic levels (ng/mL) measured by high pressure liquid chromatography (HPLC)

  Change of the plasmatic levels of Methadone \[ Time Frame: The concentrations will be measured in time: 0, 5-10, 30, 60, 120, 240 minutes of operation of the CPB and 12 or 24 hours of CPB\]

  Time Frame: 0, 5-10, 30, 60, 120, 240 minutes of operation of the CPB and 12 or 24 hours of CPB]

Study Arms (1)

Methadone Group

adult patients undergoing cardiac surgery with extracorporeal circulation

Drug: Methadone

Interventions

Methadone DRUG

Standard dose of 0.2 ug/kg before Cardiopulmonary Bypass.

Methadone Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Patients who undergo cardiac surgery whith cardiopulmonary bypass.

You may qualify if:

• Patients between 45 and 75 years old who undergo surgery of coronary bypass with CPB, univalvular replacement, bivalvular or coronary bypass plus univalvular on a scheduled basis at the UC-Christus Clinical Hospital (HCUC) and that have ASA II-III classification.

You may not qualify if:

• BMI\> 35, history of chronic liver damage, kidney damage with estimated creatinine clearance \<60 ml / min, severe ventricular dysfunction (EF \<30% or severe dysfunction in ventriculography), recent cerebrovascular accident (CVA) or sequelae, endocarditis, use of intraoperative ultrafiltration or methadone in the previous 36 hours.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico Universidad Catolica

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Related Publications (4)

• Mets B. The pharmacokinetics of anesthetic drugs and adjuvants during cardiopulmonary bypass. Acta Anaesthesiol Scand. 2000 Mar;44(3):261-73. doi: 10.1034/j.1399-6576.2000.440308.x.

  PMID: 10714838 BACKGROUND

• Starkey ES, Sammons HM. Practical pharmacokinetics: what do you really need to know? Arch Dis Child Educ Pract Ed. 2015 Feb;100(1):37-43. doi: 10.1136/archdischild-2013-304555. Epub 2014 Aug 13.

  PMID: 25122157 BACKGROUND

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.

  PMID: 25837528 BACKGROUND

• Salas WE, Cortinez LI, Lopez RA, Rolle A, Elgueta F, Godoy CO, Giordano A, Contreras V, Anderson BJ. Pharmacokinetics of Methadone in Adult Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass. Anesth Analg. 2025 Aug 1;141(2):384-392. doi: 10.1213/ANE.0000000000007312. Epub 2024 Nov 21.

  PMID: 39773745 DERIVED

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Wilbaldo Salas, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: October 2, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 1, 2023
• Last Updated: May 31, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)