Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
研究概览
简要总结
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
详细描述
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing major abdominal surgery
- •age between 18 and 70 years
- •ASA class 1 or 2
- •patients scheduled for blended anesthesia (epidural + general anesthesia)
- •patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).
排除标准
- •known or suspected respiratory, cardiovascular or neuromuscular disease
- •renal or hepatic failure
- •known or suspected allergies to drugs used in the study
- •risk for malignant hyperthermia
- •pregnancy
- •diagnosed depressive disorder
研究组 & 干预措施
Sugammadex
干预措施: sugammadex (Drug)
Sodium chloride solution
干预措施: Sodium chloride solution (Drug)
结局指标
主要结局
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
时间窗: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
时间窗: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
时间窗: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Forced Vital Capacity (FVC) changes after placebo or sugammadex
时间窗: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
次要结局
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex(10 minutes after surgery and 5 minutes later)
- Hemogasanalysis parameters changes after placebo or sugammadex(10 minutes after surgery and 5 minutes later)
- Swallow ability changes after placebo or sugammadex(10 minutes after surgery and 5 minutes later)
研究者
Federico Piccioni, MD
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano