Clinical trial · Interventional
Methadone in Cystectomy Patients
Clinical Effectiveness and Safety of Intraoperative Methadone in Patients
NCT04475029CI-TRIAL-00069539METAMORFcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Neurologic Manifestations | — | UNRESOLVED | — |
| Neurologic Symptoms | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Pathologic Processes | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Side Effect of Drug | — | UNRESOLVED | — |
| Signs and Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methadone | Drug | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Methadone
- description
- A 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.
- interventionNames
- Drug: Methadone
- type
- ACTIVE_COMPARATOR
- label
- Morphine
- description
- A 10 ml syringe with 2 mg/ml of morphine will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.
- interventionNames
- Drug: Morphine
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.