此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery

2026年7月28日 更新者:Clínica Dávila

Concordance Between Acceleromyography and Electromyography for Assessment of Neuromuscular Recovery at the End of Surgery

This prospective observational study aims to evaluate the agreement between acceleromyography and electromyography for measuring train-of-four (TOF) ratio at the end of surgery before reversal of neuromuscular blockade. Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade will undergo simultaneous TOF measurements using both monitoring methods. The study will assess the agreement between the two techniques, estimate measurement bias and limits of agreement, and determine the frequency of clinically relevant disagreement that could affect assessment of neuromuscular recovery and safe extubation.

研究概览

详细说明

Quantitative neuromuscular monitoring is recommended to reduce the incidence of residual neuromuscular blockade and its associated postoperative complications. Although electromyography is considered the current clinical reference method for objective neuromuscular monitoring, acceleromyography remains the most commonly used technique in routine clinical practice because of its availability, lower cost, and ease of use. However, acceleromyography may overestimate neuromuscular recovery, particularly when baseline normalization is not performed.

This prospective observational diagnostic agreement study will enroll adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia requiring administration of non-depolarizing neuromuscular blocking agents. At the end of surgery, before administration of neuromuscular blockade reversal agents, simultaneous train-of-four (TOF) ratio measurements will be obtained using acceleromyography and electromyography. Acceleromyography will be performed according to routine clinical practice without baseline normalization, while electromyography will serve as the reference method.

The primary objective is to evaluate the agreement between acceleromyography and electromyography measurements obtained at the end of surgery. Secondary objectives include estimating the mean bias between methods, calculating the 95% limits of agreement using Bland-Altman analysis, evaluating proportional bias, and determining the proportion of patients in whom acceleromyography indicates adequate neuromuscular recovery (TOF ≥0.9) while electromyography demonstrates residual neuromuscular blockade (TOF <0.9).

Demographic, clinical, and anesthetic variables will also be collected. Approximately 70 participants are expected to be enrolled.

研究类型

观察性的

注册 (估计的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、智利、8431657

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade at Clínica Dávila.

描述

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
  • Administration of non-depolarizing neuromuscular blocking agents.
  • Written informed consent provided.

Exclusion Criteria:

  • Pre-existing neuromuscular disease.
  • Upper extremity abnormalities preventing neuromuscular monitoring.
  • Contraindications to neuromuscular monitoring.
  • Refusal or inability to provide informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Adults Undergoing Elective Laparoscopic Cholecystectomy
Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade. Simultaneous train-of-four (TOF) ratio measurements will be obtained at the end of surgery using acceleromyography and electromyography before administration of neuromuscular blockade reversal agents.
Simultaneous quantitative neuromuscular monitoring using acceleromyography and electromyography to measure the train-of-four (TOF) ratio at the end of surgery before administration of neuromuscular blockade reversal agents.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios
大体时间:At the end of surgery, before administration of neuromuscular blockade reversal agents
Agreement between the train-of-four (TOF) ratios measured simultaneously by acceleromyography and electromyography at the end of surgery. Agreement between the two measurement methods will be evaluated using Bland-Altman analysis.
At the end of surgery, before administration of neuromuscular blockade reversal agents

次要结果测量

结果测量
措施说明
大体时间
Mean Bias Between Acceleromyography and Electromyography TOF Ratios
大体时间:At the end of surgery, before administration of neuromuscular blockade reversal agents
Mean difference between the TOF ratio measured by acceleromyography and the TOF ratio measured by electromyography.
At the end of surgery, before administration of neuromuscular blockade reversal agents
Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods
大体时间:At the end of surgery, before administration of neuromuscular blockade reversal agents
Upper and lower 95% limits of agreement for the difference between acceleromyography and electromyography TOF ratio measurements, calculated using Bland-Altman analysis.
At the end of surgery, before administration of neuromuscular blockade reversal agents
Proportional Bias Between Acceleromyography and Electromyography TOF Ratios
大体时间:At the end of surgery, before administration of neuromuscular blockade reversal agents
Presence and magnitude of proportional bias between the two monitoring methods, evaluated by assessing the relationship between the difference in TOF ratios and the mean TOF ratio obtained by acceleromyography and electromyography.
At the end of surgery, before administration of neuromuscular blockade reversal agents
Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography
大体时间:At the end of surgery, before administration of neuromuscular blockade reversal agents
Proportion of participants in whom acceleromyography indicates adequate neuromuscular recovery, defined as a TOF ratio greater than or equal to 0.90, while electromyography indicates residual neuromuscular blockade, defined as a TOF ratio below 0.90.
At the end of surgery, before administration of neuromuscular blockade reversal agents

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dagoberto Ojeda, MD、Clínica Dávila

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年7月24日

首先提交符合 QC 标准的

2026年7月28日

首次发布 (实际的)

2026年7月31日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared. Only aggregate study results will be reported in scientific publications and presentations. Participant confidentiality will be protected in accordance with institutional policies and applicable ethical and regulatory requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅