Status:
COMPLETED
Methadone in Cystectomy Patients
Lead Sponsor:
University of Aarhus
Conditions:
Pain, Postoperative
Postoperative Complications
Eligibility:
All Genders
18-110 years
Phase:
NA
Brief Summary
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, randomiz...
Detailed Description
During early recovery after surgery, intravenous opioids are typically administered to control the pain, either as intermittent bolus administration by nursing staff or by a patient-controlled analges...
Eligibility Criteria
Inclusion
- \- All patients (≥18 years) scheduled for elective robot assisted cystectomy.
Exclusion
- 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
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2023
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04475029
Start Date
July 6 2020
End Date
August 17 2023
Last Update
September 13 2023
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200