Concordance Between Acceleromyography and Electromyography for Assessment of Neuromuscular Recovery at the End of Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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.
排除标准
- •Pre-existing neuromuscular disease.
- •Upper extremity abnormalities preventing neuromuscular monitoring.
- •Contraindications to neuromuscular monitoring.
- •Refusal or inability to provide informed consent.
结局指标
主要结局
Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios
时间窗: 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.
次要结局
- Mean Bias Between Acceleromyography and Electromyography TOF Ratios(At the end of surgery, before administration of neuromuscular blockade reversal agents)
- Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods(At the end of surgery, before administration of neuromuscular blockade reversal agents)
- Proportional Bias Between Acceleromyography and Electromyography TOF Ratios(At the end of surgery, before administration of neuromuscular blockade reversal agents)
- Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography(At the end of surgery, before administration of neuromuscular blockade reversal agents)