The Effect of Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium of Elderly Patients Undergoing Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Interleukin 6
研究概览
简要总结
The purpose of the study is to determine the relationship between the degree of neuromuscular block, the release of cytokines and clinical outcomes in elderly patients undergoing orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade decreases the release of cytokine and the incidence of postoperative delirium in elderly patients undergoing orthopedic surgery, compared with moderate neuromuscular blockade.
详细描述
- Study design
- This is a prospective, randomized, single blinded study.
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Measurement values
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Neuromuscular monitoring by post-tetanic count (PTC) during operation
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Regional cerebral oxygen saturation monitoring
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Mean systemic blood pressure (MBP), heart rate (HR)
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Cardiac index (CI), using non-invasive cardiac output monitor
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IL-1ß, IL-6, TNF-α, IL-10 and CRP
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Arterial blood gas analysis (ABGA)
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Laboratory values [Hemoglobin, Hematocrit, serum albumin, creatinine, CPK, LDH]
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Postoperative pain, using visual analogue scale (VAS)
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Postoperative nausea and vomiting (PONV)
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Total infused amounts of drugs
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Total anesthesia duration, intubation duration and operation duration
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Intubation duration, operation duration
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Incidence of postoperative intensive care unit (ICU) admission
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Total ICU staying duration, if patients admit to ICU
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Preoperative and postoperative left ventricular ejection fraction change
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Incidence of hypotension (mean blood pressure lesser than 60 mmHg)
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Incidence of postoperative delirium using confusion assessment method (CAM) intensive care unit (ICU)
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Total amount of blood products transfusion (paced red blood cells, fresh frozen plasma, platelet concentration, cryoprecipitate)
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Total amount of crystalloids and colloids infusion
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Total amount urine output
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (more than 50 years old) patients scheduled for total hip arthroplasty and total knee arthroplasty who have signed the written informed consent.
排除标准
- •Inability to give informed consent
- •Preexisting cognitive dysfunction or delirium
- •Known allergy to rocuronium sugammadex
- •Underlying liver dysfunction (AST and ALT more than 100 IU/l)
- •Underlying kidney dysfunction (Serum Creatinine more than 1.5 mg/dl)
- •Underlying neuromuscular disease
- •Patients taking any medication with potential interference with neuromuscular transmission
结局指标
主要结局
Interleukin 6
时间窗: postoperative 4 hours
次要结局
- postoperative delirium(up to postoperative day 7)
研究者
Seong-Hyop Kim
Associate Professor
Konkuk University Medical Center