CompletedPhase 2
The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
Key facts
- Who runs it
- Radboud University Medical Center
- Where
- Netherlands1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 20 people enrolled
- Started
- 21 Mar 2023
- Ended
- 23 Nov 2023
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Sugammadex 100 MG/ML [Bridion]
- Placebo
- Record updated
- 28 November 2023
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Age of 18 years or older
- Scheduled for total hip replacement surgery under neuraxial anesthesia
- Scheduled for primary hip replacement surgery
- Informed consent obtained
Who cannot take part
- Chronic use of psychotropic drugs
- Chronic use of NSAID's, steroids or immunosuppressive drugs
- Known or suspected hypersensitivity to sugammadex
- Severe liver disease (Child-Pugh Classification C)
- Severe vertebral column disorder
- Severe renal disease (creatinine clearance <30 ml/min), including patients on dialysis)
- Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
- Mentally incapacitated patients
- Deficiency of vitamin K dependent clotting factors or coagulopathy
- Women who are or may be pregnant or currently breastfeeding
- Women of childbearing potential who don't use adequate method of contraception
- Known hypertrophic obstructive cardiomyopathy, severe aortic valve stenosis or severe mitral valve stenosis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Monocenter randomized controlled proof of principle study to investigate the effect of sugammadex at the end of total hip replacement surgery on the postoperative innate immune function
The 2 groups in the trial
- SugammadexTreatment being tested
Sugammadex administration at the end of surgery
Treatment: Sugammadex 100 MG/ML [Bridion]
- PlaceboPlacebo, for comparison
Placebo administration at the end of surgery
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 28 November 2023