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临床试验/NCT03489785
NCT03489785Unknown不适用

Predictive Factors of Unpredicted Movement in Motor Evoked Potential During Intraoperative Neurophysiologic Monitoring in Adult Patients Undergoing Brain Surgery.

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2003年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
850
试验地点
1
主要终点
Predictive factors of unpredicted movement

研究概览

简要总结

The purpose of this study was to identify the predictive factors of unpredicted movement in motor evoked potential (MEP) during intraoperative neurophysiologic monitoring in adult patients undergoing brain surgery.

详细描述

Despite advances in neuroendovascular techniques, several complications can occur by brain urgery. Therefore, for neurosurgeons and anesthesiologists, it is a major concern to describe and monitor surgical lesion for maintaining structural and functional integrity as well as achieving maximal cytoreduction in lesion, and modifying the management of patients on the process of surgery. For example, microvascular Doppler sonography, indocyanine green aniography, intraoperative digital subtraction angiography, and intraoperative neurophysiologic monitoring (IONM) are used for this purpose.

The incidence of unpredictable and unacceptable movement is relative low. However, the results are so horrendous that they can cause injuries in site of rigid pin fixation of the head, cervical spine injuries, excessive surgical field movement, and deterioration of surgical outcome. However, risk factors associated with unpredictable and unacceptable movement remain unclear. Therefore, the aim of this retrospective study was to evaluate risk factors associated with unpredictable and unacceptable movement in the patients who underwent brain surgery with MEP monitoring under general anesthesia while using neuromuscular blocking agent.

The investigators recorded demographic data including age in years, sex, height in meters, weight in kilograms, body mass index (BMI in kg/m^2), ASA physical status class, diagnosed disease, performed surgical procedure, duration of anesthesia in minutes, duration of surgery in minutes, underlying disease (e.g. hypertension, diabetes, neurologic disease, respiratory disease), medications. Laboratory data was also collected including arterial blood gas analysis, hematocrit, hemoglobin, sodium, potassium, ionized calcium, ionized magnesium, and lactate. Unpredictable and unacceptable movement was defined as either the dangerous gross movement requiring the increase the continuous infusion rate of rocuronium in view of the surgeon, anesthesiologist, and neurophysiologic specialist or the shake of the surgical field requiring the increase the continuous infusion rate of rocuronium.

研究设计

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

入排标准

年龄范围
19 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital.

排除标准

  • Age : 18 or younger and 75 or older
  • Anesthesiologists physical status classes III or more
  • body mass index(BMI) < 18.5 kg/m^2 or BMI > 25 kg/m^2
  • Patients who received medications that affect muscle relaxation recovery other than anticonvulsants
  • OT/PT > 40 IU/L, Cr > 1.4 mg/dl
  • Moderate to severe respiratory or heart disease

结局指标

主要结局

Predictive factors of unpredicted movement

时间窗: during brain surgery

The investigators retrospectively compare the data of patients with and without unpredictable and unacceptable movement during surgery. For continuous variables, values were compared using the independent t-test. Differences in proportions were compared using chi-square test. Variables with P-values \< 0.05 in the primary test were selected and univariate binary logistic regression analyses were conducted to identify the factors predictive of an unpredictable and unacceptable movement. P-value \< 0.05 was considered statistically significant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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