Overview

Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy

Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
0
Participant gender:
Female
Summary
The role of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in patients undergoing hysterectomy remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative methadone in patients scheduled for same day hysterectomy is therefore conducted.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Aarhus
Treatments:
Methadone
Morphine
Criteria
Inclusion Criteria:

- Patients scheduled for elective laparoscopic hysterectomy for benign indications

Exclusion Criteria:

- American Society of Anaesthesiologists (ASA) physical status IV or V

- prolonged QT-interval assessed by electrocardiogram (> 440 milliseconds)

- Existing treatment with medications prolonging the QT-interval

- Hysterectomy due to malignancy or acute bleeding disorders

- Allergy to study drugs

- Preoperative daily use of opioids

- Severe respiratory insufficiency

- Heart failure

- Acute alcohol intoxication/delirium tremens

- Increased intracranial pressure

- Acute liver disease

- Acute abdominal pain

- Liver insufficiency

- Kidney insufficiency

- Treatment with rifampicin

- Breastfeeding

- Inability to provide informed consent.