The immunomodulatory effect of sugammadex after total hip replacement surgery under neuraxial anaesthesia: a pilot study

Phase 2

Completed

• Conditions: hip arthrosis; Osteoarthritis; 10005944

• Registration Number: NL-OMON51373
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-11-23
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 23

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

Exclusion Criteria

- Insufficient control of the Dutch language to read the patient information
and to fill out de questionnaires
- Mentally incapcitated patients
- 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
- Women of childbearing potential who don't use adequate method of contraception
- Severe vertebral column disorder
- Chronic use of psychotropic drugs
- Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis
or severe mitral valve stenosis
- Chronic use of NSAID's, steroids or immunosuppressive drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative innate immune function as reflected by<br /><br>- Ex vivo cytokine (TNF-a, IL-6, IL-10, IL-1&beta;) production capacity of<br /><br>mononuclear cells upon whole blood lipopolysaccharide (LPS) stimulation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Innate immune function at the end of surgery and postoperative day 1 as<br /><br>reflected by<br /><br>- Circulating inflammatory cytokines (TNF-a, IL-6, IL-10)<br /><br>- DAMP release (HSP70, HMGB1)<br /><br>- Pain scores (NRS 0-10) and total analgesia consumption at the post anesthesia<br /><br>care unit (PACU) and postoperative day 1.<br /><br>- Quality of Recovery score (QoR-40) at postoperative day 1(11).<br /><br>- Innate immune function prior to incision<br /><br>- 30-day postoperative infectious complications scored according to the<br /><br>relevant endpoint of the StEP-COMPAC group initiative<br /><br>- 30-day postoperative complications scored by Clavien Dindo classification.</p><br>