Bladder cancer MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: Morphine
CAS Number: 57-27-2
Other descriptive name: MORPHINE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration numbe
Sponsors
Lone Nikolajsen
Eligibility
Sex/Gender
All
Inclusion 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
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) • Severe kidney insufficiency (estimated Glomerular Filtration Rate < 30 ml/min) • Treatment with rifampicin • Treatment with MAO-inhibitor during the last 14 days • Pregnancy • Nursing mothers • Phaeochromocytoma • Intraoperative conversion to open surgery (secondary inclusion criterion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Opioid consumption within the first 3/24 hours ;Secondary Objective: •Postoperative pain intensity within the first 24 hours (at 1, 3, 6, 18, 24 hrs) •Nausea and/or vomiting at 3 and 24 hours; sedation at 3 hours. •Hypoventilation/hypoxemia in the PACU •Patient satisfaction with pain management at 24 hours after extubation •Time from arrival to readiness for discharge from PACU and hospital (hours and minutes) ;Primary end point(s): •Opioid consumption ;Timepoint(s) of evaluation of this end point: 3/24 hours after extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pain intensity (NRS, 0-10) at rest and coughing • Nausea and/or vomiting (PONV) on a 4-point Likert scale (none/mild/moderate/severe) • Level of sedation in the PACU (Ramsey sedation score) • Any adverse events during observation at the PACU: - Hypoventilation - Hypoxemia • Patient satisfaction (NRS, 0-10) with pain management • Time from arrival to readiness for discharge from PACU and hospital (hours and minutes);Timepoint(s) of evaluation of this end point: Pain - 1, 3, 6, 18 and 24 hours after extubation Nausea and/or vomiting - 3 and 24 hours Sedation - 3 hours Adverse events - hypoventilation (respiratory rate <10/minutes) - hypoxemia (peripheral oxygen saturation <94%) Patient satisfaction - 24 hours | — |
Countries
Denmark
Contacts
Public ContactLone Nikolajsen
Aarhus University Hospital
Outcome results
None listed