Cardiopulmonary Bypass Clinical Trial
Official title:
Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | April 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Pontificia Universidad Catolica de Chile |
Mets B. The pharmacokinetics of anesthetic drugs and adjuvants during cardiopulmonary bypass. Acta Anaesthesiol Scand. 2000 Mar;44(3):261-73. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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] | |
Primary | 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] |
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