Deep Versus Moderate Neuromuscular Blockade During Total HIP Replacement Surgery to Improve POstoperative Quality of Recovery and Immune Function: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality of Recovery 40 (QoR-40) questionnaire score
研究概览
简要总结
Monocenter randomized controlled trial to compare the effect of deep neuromuscular blockade (NMB) versus moderate NMB during total hip replacement surgery on postoperative quality of recovery and innate immune function.
详细描述
Rationale: Neuromuscular blockade agents (NMB) may enable surgeons to optimize exposure during hip surgery. With an increasing depth of NMB, manipulation of muscles and adjunctive tissues may be easier, therefore reducing damage to muscles and adjunct tissues. Accumulating evidence exists that the use of deep NMB in laparoscopic surgery is associated with a better quality of recovery and lower pain scores. However, whether this accounts for open surgery is still unknown.
In addition, surgery is associated with postoperative immune suppression. Surgical stress and damage cause the release of Danger Associated Molecular Patterns (DAMPs). After trauma and sepsis, the release of DAMPs is associated with immune paralysis and a higher susceptibility to infectious complications. Previous research indicates that DAMPS are the origin of postoperative immune suppression. The use of deep NMB in hip surgery may reduce surgical damage and thereby lead to a better quality of recovery and secondarily a better preservation of immune cell function.
Primary objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) versus moderate NMB and the quality of recovery after total hip replacement surgery (THR) Secondary objective: To establish the relationship between the use of deep NMB versus moderate NMB and innate immune function after THR surgery
Study design: A monocenter, blinded, randomized controlled clinical trial
Study population: adults who are scheduled for primary or secondary hip replacement surgery under general 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 general anaesthesia
- •Informed consent obtained
排除标准
- •Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
- •Known or suspected hypersensitivity to rocuronium or 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)
- •Known or suspected neuromuscular disorders impairing neuromuscular function
- •Women who are or may be pregnant or currently breastfeeding
- •Chronic use of psychotropic drugs
- •Use of immunomodulatory medication
研究组 & 干预措施
Deep neuromuscular blockade
Participant will receive deep neuromuscular blockade (PTC 1-2)
干预措施: Rocuronium Bromide (Drug)
Moderate neuromuscular blockade
Participant will receive moderate neuromuscular blockade (TOF 1-2)
干预措施: Rocuronium Bromide (Drug)
结局指标
主要结局
Quality of Recovery 40 (QoR-40) questionnaire score
时间窗: Postoperative day 1
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
次要结局
- Immune function represented by ex-vivo IL-10 production capacity(Postoperative day 1)
- Postoperative complications(30 postoperative days)
- Immune function represented by TNF-a(Postoperative day 1)
- Immune function represented by ex-vivo IL-6 production capacity(Postoperative day 1)
- Quality of Recovery 40 (QoR-40) questionnaire score(Postoperative day 30)
- Immune function represented by IL-10(Postoperative day 1)
- Infectious postoperative complications(30 postoperative days)
- Immune function represented by serum cytokine(Postoperative day 1)
- Pain score by numeric pain rating (NRS) scale(During hospital admission up to 3 days postoperative)
- Analgesia consumption(During hospital admission up to 3 days postoperative)