Clinical effectiveness and safety of intraoperative methadone in patients undergoing cystectomy: a randomised, double-blind trial

INTERVENTION: 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 number: 10‐ Trade Name: Methadone Streuli Sol Inj 10 mg/ml 10 AMPS 1 ML Pharmaceutical Form: INN or Proposed INN: METHADONE CAS Number: 76‐99‐3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: 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) Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: • Opioid consumption within the first 3/24 hours Primary end point(s): • Opioid consumption 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) ; Timepoint(s) of evaluation of this end point: 3/24 hours after extubation SECONDARY OUTCOME: 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 ; 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