The Immunomodulatory Effect of Sugammadex After Total Hip Replacement Surgery Under Neuraxial Anaesthesia: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative innate immune function
研究概览
简要总结
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
详细描述
Rationale: With infections being the number one complication after surgery, more research is aimed at therapeutic strategies that positively influence the postoperative immune dysregulation. In the search for reducing surgical stress by a deep neuromuscular block (NMB), our group recently found evidence that sugammadex, used to antagonize a deep NMB, may have an immunomodulatory effect. Ex vivo analysis showed that sugammadex counteracted the immunosuppressive effect of rocuronium, but even in absence of rocuronium it had a positive effect on cytokine production capacity.
Therefore, we now propose a clinical pilot study in patients planned for total hip surgery under neuraxial anaesthesia to further investigate whether sugammadex has beneficial immunomodulatory effects.
Primary objective: To investigate the effect of sugammadex on the postoperative innate immune function.
Study design: A blinded, randomized controlled pilot study
Study population: 20 adults scheduled for primary hip replacement surgery under neuraxial anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older
- •Scheduled for total hip replacement surgery under neuraxial anesthesia
- •Scheduled for primary hip replacement surgery
- •Informed consent obtained
排除标准
- •Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
- •Mentally incapacitated 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
研究组 & 干预措施
Sugammadex
Sugammadex administration at the end of surgery
干预措施: Sugammadex 100 MG/ML [Bridion] (Drug)
Placebo
Placebo administration at the end of surgery
干预措施: Placebo (Other)
结局指标
主要结局
Postoperative innate immune function
时间窗: Postoperative day 1
Ex vivo cytokine production capacity (TNF-α, IL-6, IL-10, IL-1β) of mononuclear cells upon whole blood Lipopolysaccharide(LPS) stimulation
次要结局
- Postoperative innate immune function(3 timepoints: Postoperative day 1, at the start of surgery (±30 minutes after administration neuraxial anesthesia), and at the end of surgery (±15 minutes after administration intervention/placebo medication))
- Postoperative complications(Postoperative day 30)
- Pain and total analgesia consumption(During hospital admission up to 3 days postoperative)
- Postoperative infectious complications(Postoperative day 30)
- Quality of Recovery(Postoperative day 1)