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临床试验/NCT07758868
NCT07758868尚未招募不适用

Incidence and Clinical Implications of Residual Neuromuscular Blockade in Patients Planned for Post-Anesthesia Care Unit Admission: A Prospective Observational Study

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
The primary outcome of this study was to investigate the incidence of postoperative residual neuromuscular blockade in patients identified as high risk during the preoperative assessment and to evaluate the associated clinical differences.

研究概览

简要总结

Residual neuromuscular blockade (RNMB) remains an underrecognized postoperative safety concern associated with pulmonary complications, prolonged post-anesthesia care unit stay, and reduced patient satisfaction. Because conventional clinical tests are insufficiently sensitive and specific, current guidelines recommend quantitative neuromuscular monitoring to confirm adequate recovery, defined as a train-of-four ratio of ≥0.9.

This prospective observational study included adult patients aged 18-90 years with ASA physical status I-III who underwent elective surgery under general anesthesia with neuromuscular blocking agents. Demographic, clinical, anesthetic, surgical, and reversal-related variables were recorded. Postoperative neuromuscular recovery was quantitatively assessed at the adductor pollicis muscle using TOFscan® acceleromyography at the 10th postoperative minute. Patients were subsequently followed in either the PACU or surgical ward according to clinical indications, and postoperative adverse events were documented. The study aimed to evaluate the incidence and potential determinants of RNMB in accordance with contemporary neuromuscular monitoring guidelines.

详细描述

Residual neuromuscular blockade (RNMB) remains an important patient safety concern throughout the postoperative period and continues to be underrecognized by healthcare professionals. Current evidence suggests that RNMB is associated with an increased risk of postoperative pulmonary complications, prolonged length of stay in the post-anesthesia care unit (PACU), and reduced patient satisfaction.

Clinical assessment methods may include, but are not limited to, a 5-second head lift, sustained hand grip, eye opening, tongue protrusion, and the presence of spontaneous ventilation. Although these tests are commonly used by anesthesiologists, they lack sufficient sensitivity and specificity for the detection of RNMB.

The 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade provide recommendations regarding the use of quantitative neuromuscular monitoring in conjunction with pharmacological reversal to improve the recognition of RNMB and reduce its incidence. These guidelines recommend quantitative monitoring because it enables more reliable confirmation of a train-of-four ratio (TOFR) of ≥0.9 compared with qualitative assessment methods.

The use of quantitative neuromuscular monitoring to assess the depth of neuromuscular blockade may substantially reduce the risk of RNMB in patients undergoing general anesthesia. Several studies have also investigated whether combining pharmacological reversal of neuromuscular blockade with quantitative monitoring may further improve postoperative patient safety.

Patients scheduled for postoperative admission to the PACU commonly have significant comorbidities and higher American Society of Anesthesiologists physical status classifications. Therefore, postoperative RNMB may be particularly critical in this high-risk patient population. The present study was designed to evaluate postoperative neuromuscular recovery in accordance with current evidence-based guidelines.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III who underwent elective surgery under general anesthesia and received a neuromuscular blocking agent were included in the study.

排除标准

  • •Patients younger than 18 years or older than 90 years, those requiring postoperative invasive mechanical ventilation and transfer to the intensive care unit while intubated, patients undergoing emergency surgery, and those with a pre-existing neuromuscular disorder were excluded from the study.

研究组 & 干预措施

Patients scheduled for ward admission

Patients for whom postoperative admission to the post-anesthesia care unit (PACU) was not planned during the preoperative assessment

Patients scheduled for postoperative admission to the post-anesthesia care unit (PACU)

No study-specific intervention was planned for either group. Patients whose postoperative admission to the post-anesthesia care unit (PACU) had been planned on the basis of the preoperative assessment and the decision of the attending physician constituted the PACU group.

结局指标

主要结局

The primary outcome of this study was to investigate the incidence of postoperative residual neuromuscular blockade in patients identified as high risk during the preoperative assessment and to evaluate the associated clinical differences.

时间窗: Perioperative period, including follow-up until the 30th postoperative minute.

Patients scheduled for postoperative admission to the post-anesthesia care unit generally represent a population with a greater burden of comorbidities and higher American Society of Anesthesiologists physical status classifications. Therefore, postoperative residual neuromuscular blockade may be of greater clinical significance in this patient population. This study was designed to evaluate postoperative neuromuscular recovery in accordance with current guideline recommendations.

次要结局

  • seconder outcome(From the preoperative assessment through the intraoperative period and during the postoperative follow-up period for 24 hours.)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gizem Avci

Principal Investigator

Ankara Etlik City Hospital

研究点 (1)

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