Clinical trial

Influence of Aging on Perioperative Methadone Dosing

Name

190510001

Description

Increasingly, elderly patients undergo anesthesia and surgery. Methadone is a great opioid for perioperative pain management, however, to date there are no pharmacokinetic or pharmacodynamic studies that asses a methadone dose adjustment in the elderly patient. The present study is aimed to characterize the pharmacokinetic and pharmacodynamic age-related changes of methadone in the adult population and further to design reference dosing protocols for intraoperative methadone use according to patient age.

Trial arms

Trial start

2019-09-03

Estimated PCD

2022-07-13

Trial end

2022-07-13

Status

Completed

Phase

Early phase I

Treatment

Methadone Injectable Product

Perioperative use of placebo for pain management and remifentanil during the surgery.

Arms:

Methadone 0, Methadone 1, Methadone 2, Methadone 3

Other names:

Methadone 0, Methadone 1 0,05 mg/kg, Methadone 2 0,1 mg/kg, Methadone 3 0,2 mg/kg

Size

Primary endpoint

Methadone plasmatic levels Measured by high pressure liquid chromatography

From the first dose up to 24 hours.

Eligibility criteria

Inclusion Criteria: 1. Over 18 years. 2. ASA I, II or III. 3. Laparoscopic Abdominal Surgery. Exclusion Criteria: 1. BMI\> 35 2. Use of opioids up to 5 days before surgery. 3. Acute Liver Failure or Chronic Liver Damage Child C. 4. Kidney damage with creatinine clearance estimated by Cockcroft-Gault formula \<60 ml/min.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly divided into four groups according to the dose of intravenous methadone to be administered during anesthetic induction, for a total number of 60 patients.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The masking will be generated on a research laboratory computer and will be stored in an encrypted file. This information will be known exclusively to a member of the research team present during the surgery, who will hand over preparing the corresponding medicine in a 20 cc syringe and hand it over to the treating anesthesiologist.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-12-21

1 organization

1 product

4 indications

Organization

Pontificia Universidad Catolica de Chile

Product

Indication

Indication

Indication

Indication