Clinical Effectiveness and Safety of Intraoperative Methadone in Patients

004581

The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.

2020-07-06

2023-08-15

2023-08-17

Completed

114

Inclusion Criteria: - All patients (≥18 years) scheduled for elective robot assisted cystectomy. Exclusion Criteria: * American Society of Anesthesiologists (ASA) physical status IV or V * Prolonged QTc-interval assessed by electrocardiogram (\> 440 milliseconds) * Existing treatment with a high risk of QTc-interval prolongation * Allergy to study drugs * Preoperative daily use of opioids * Inability to provide informed consent * Severe respiratory insufficiency (oxygen treatment at home) * Heart failure (ejection fraction \< 30%) * Acute abdominal pain * Signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancy) * Severe kidney insufficiency (estimated Glomerular Filtration Rate \< 30 ml/min) * Treatment with rifampicin * Phaeochromocytoma * Treatment with MAO-inhibitor during the last 14 days * Pregnancy * Nursing mothers * Intraoperative conversion to open surgery (secondary inclusion criterion) * Epidural analgesia in relation to surgical procedure

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Randomization and medication will be handled by hospital pharmacy. Randomisation list will be concealed until all statistical analyses are made.\n\n* plan for data analysis was decided upon at a meeting with a statistician on September 7th, 2023. The plan was made before A and B lists were obtained from the hospital pharmacy. This study will be undertaken as an equivalence trial with the application of intention to treat analysis. Missing data are assumed to be missing at random. Primary outcome will be analyzed paired or unpaired t-test for difference, depending on distribution. Analysis of secondary outcome NRS will be reported as median(interquartile range) and compared between groups at the various times using the Mann-Whitney U test. If normal distributed multilevel mixed effects linear regression will be carried out. Analysis of other secondary outcomes will be dichotomized and presented for 3 and 24 hours with X2 test.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 114, 'type': 'ACTUAL'}}

2023-09-13