Same-day hysterectomy MedDRA version: 21.1 Level: LLT Classification code 10023692 Term: Laparoscopically assisted hysterectomy System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Methadon Streuli Sol Inj 10mg/ml 10AMPS 1ML
Pharmaceutical Form:
INN or Proposed INN: METHADONE
CAS Number: 76-99-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients scheduled for elective laparoscopic hysterectomy for benign indications are screened for inclusion 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: Patients with one of the following criteria are excluded: • American Society of Anaesthesiologists (ASA) physical status IV or V [21]: • Prolonged QT-interval assessed by electrocardiogram (> 440 milliseconds). • Existing treatment with medications prolonging the QT-interval (see appendix for details) • Hysterectomy due to malignancy or acute bleeding disorders • Allergy to study drugs • Preoperative daily use of opioids or • Inability to provide informed consent Secondary exclusion criteria: • Intraoperative conversion to open surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to investigate the effect of a single dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for hysterectomy for benign indications. A single dose of intravenous intraoperative morphine will be used as an active comparator.;Secondary Objective: • Pain intensity (NRS, 0-10) at rest and coughing at 0.5, 1, 3, 6, 24, 48 and 72 hours after extubation • Patient satisfaction (NRS, 0-10) with pain management at 3 and 24 hours after extubation • Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) at 6, 24 and 72 hours • Time from arrival to readiness for discharge from PACU and hospital (hours and minutes). • Level of sedation at observation at the PACU (Ramsay Sedation Scale [20] at 0.5, 1 and 3 hours after extubation) • Any adverse events during observation at the PACU: o Hypoventilation (respiratory rate < 10/minutes) o Hypoxemia (peripheral oxygen saturation < 90%) ;Primary end point(s): Primary outcomes: • Opioid consumption at 24 hours (mean cumulative opioid consumption) • Opioid consumption at 6 hours after extubation (mean cumulative opioid consumption) ;Timepoint(s) of evaluation of this end point: 6 and 24 hours after extubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes: • Pain intensity (NRS, 0-10) at rest and coughing at 0.5, 1, 3, 6, 24, 48 and 72 hours after extubation • Patient satisfaction (NRS, 0-10) with pain management at 3 and 24 hours after extubation • Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) at 6, 24 and 72 hours • Time from arrival to readiness for discharge from PACU and hospital (hours and minutes). • Level of sedation at observation at the PACU (Ramsay Sedation Scale [20] at 0.5, 1 and 3 hours after extubation) • Any adverse events during observation at the PACU: o Hypoventilation (respiratory rate < 10/minutes) o Hypoxemia (peripheral oxygen saturation < 90%);Timepoint(s) of evaluation of this end point: 0.5, 1, 3, 6, 24, 48 and 72 hours after extubation and 4 months after surgery. | — |
Countries
Denmark
Contacts
Public ContactLone Nikolajsen
Aarhus University Hospital
Outcome results
None listed