The effect of sugammadex on the postoperative immune function after total hip replacement under neuraxial anesthesia

Phase 1

• Conditions: Hip osteoarthritis; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2022-003325-22-NL
• Lead Sponsor: RadboudUMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-07
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Age of 18 years or older
- Scheduled for total hip replacement surgery under neuraxial surgery
- Scheduled for primary hip replacement surgery
- Informed consent obtained
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
- Known or suspected hypersensitivity to sugammadex
- Deficiency of vitamin K dependent clotting factors or coagulopathy
- Severe renal disease (creatinine clearance <30 ml/min), including patients on dialysis)
- Severe liver disease (Child-Pugh Classification C)
- Women who are or may be pregnant or currently breastfeeding
- Severe vertebral column disorder
- Chronic use of psychotropic drugs
- Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosis
- Use of immunomodulatory medication

Study & Design

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