Intraoperative methadone in orthopedic surgery.

Phase 1

• Conditions: Orthopedic surgery; MedDRA version: 23.1Level: LLTClassification code 10051079Term: Orthopedic procedureSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2023-000172-36-BE
• Lead Sponsor: CHU Brugmann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-30
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Age between 18 and 80 years old
ASA 1-3 status
Elective partial or total hip and knee arthroplasty

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 25

Exclusion Criteria

Patient refusal
Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold increase in basal plasma creatinine or GFR < 50 ml/min/1.73m2)
Significant hepatic dysfunction (PT <50% or increase in 3 times basal transaminases)
Known heart failure
Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)
Known methadone or sufentanil allergy
Preoperative opioid use or history of opioid abuse
Pregnancy and breastfeeding
Treatment with beta blockers and HR < 60 bpm
Treatment with antidepressants

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified