EUCTR2019-004581-18-DK
Active, not recruiting
Phase 1
Clinical effectiveness and safety of intraoperative methadone in patients undergoing cystectomy: a randomised, double-blind trial
one Nikolajsen0 sites110 target enrollmentJanuary 24, 2020
ConditionsBladder cancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Bladder cancer
- Sponsor
- one Nikolajsen
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients
- •\= 18 years
- •Planned for bladder removal
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 55
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 55
Exclusion Criteria
- •American Society of Anesthesiologists (ASA) physical status IV or V (21\)
- •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)
Outcomes
Primary Outcomes
Not specified
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