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临床试验/NCT03503565
NCT03503565已完成不适用

The Effect of Intraoperative Neuromuscular Blockade on Postoperative Atelectasis in Patients Undergoing Thoracic Surgery With One Lung Ventilation: Moderate vs. Deep Block

Kyung Hee University Hospital at Gangdong1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2018年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
1
主要终点
Atelectasis Area on Chest CT

研究概览

简要总结

During one-lung ventilation in thoracic surgery, the intensity of neuromuscular blockade may change the compliance and resistance of ventilated lung, thereby affecting postoperative atelectasis. The present study investigated the effect of the intensity of intraoperative neuromuscular blockade on the postoperative atelectasis using chest computerized tomography in patients receiving thoracic surgery requiring one-lung ventilation.

详细描述

Neuromuscular blocking agents can be used to secure a good surgical field, but it can also cause delayed extubation or postoperative pulmonary complications. Traditionally, rocuronium which is a commonly used non-depolarizing agent is usually reversed by cholinesterase inhibitors such as neostigmine or pyridostigmine. These drugs act by increasing the concentration of acetylcholine at the neuromuscular junction (a competing antagonist), not by direct antagonists. Consequently, there is a risk of pulmonary complications when cholinesterase inhibitor is not used appropriately. Use of sugammadex can reverse neuromuscular blockade (NMB) quickly, thereby being helpful for spontaneous deep breathing postoperatively. In a previous study, the moderate neuromuscular blockade was not guaranteed during surgery because intraoperative train-of-four (TOF) monitoring was not used and the outcome was focused on the correlation between reversal agent and the overall incidence of postoperative pulmonary complications. However, in the present study, TOF ratio or post-tetanic count (PTC) was repeatedly measured during surgery, thereby the intensity of intraoperative NMB being maintained. Moreover, lung compliance was repeatedly measured during surgery and the correlation between the intensity of intraoperative NMB and postoperative atelectasis which is evaluated by quantitative technique was also investigated.

Particularly in thoracic surgery, one lung ventilation is usually required for the surgical procedure. During one-lung ventilation, the compliance of ventilated lung is decreased and resistance can be increased, thereby the risk of atelectasis being increased. Furthermore, after thoracic surgery, although patients were encouraged to deep breathe, it is difficult to take a deep breath because of various factors. (i.e. pain, chest tube, long retracted time, postoperative interstitial edema, etc.) Therefore, postoperative atelectasis is much more important in patients undergoing thoracic surgery than other types of surgery.

For preventing postoperative atelectasis, the intraoperative intensity of neuromuscular blockade can be a crucial factor. Because deep neuromuscular blockade provides a good lung compliance during mechanical ventilation, peak inspiratory pressure can be decreased, thereby reducing the risk of ventilation-induced lung injury, particularly in one lung ventilation situation.However, there has been still lack of quantitative evidence that deep block is superior to moderate block in the thoracic surgery with one-lung ventilation

For assessment of postoperative atelectasis, plain chest radiography may be used. However, plain chest radiography can provide only a qualitative assessment of atelectasis. Computed tomography can assess the whole lung by its density (HU) and enables a quantitative assessment of postoperative atelectasis. Moreover, it can indicate the location of atelectasis more clearly than plain chest radiography, thus provide detailed information about postoperative lung state. To assess the effect of maintaining deep block and sugammadex reversal on the postoperative atelectasis, using chest CT can provide a much more quantitative and valuable information than conventional chest radiography.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving scheduled unilateral lung lobectomy.
  • Patients age ≥19
  • Patients of American Society of Anesthesiologist Physical Status 1 or 2

排除标准

  • Patients receiving bilateral lung lobectomy
  • Patients BMI > 35.0 or < 18.5 kg/m2
  • Patients of contraindicated to epidural patients controlled analgesia
  • Patients with neuromuscular disease (i.e. myasthenia gravis)
  • Patients with major burn (more than 3rd degrees)
  • Patients with compromised cardiopulmonary function.

结局指标

主要结局

Atelectasis Area on Chest CT

时间窗: 1 day after the end of surgery

Atelectasis on Chest CT The lung area was delineated manually. To calculate atelectasis, a region of interest was laid out that encircled the dense part of the lung, excluding large vessels. For further analysis, the lung was divided into four categories: areas with densities ranging from -1000 to -900 Hounsfield units (HU) were classified as over-aerated, from -900 to -500 HU as normally aerated, from -500 to -100 HU as poorly aerated, and from -100 to +100 HU as non-aerated (atelectasis). The proportion of non-aerated lung tissue (-100 to +100 HU) was calculated by dividing the area of the region of interest with the whole lungs.

次要结局

  • Number of Patients Defined as Pneumonia(up to 7 days after the end of surgery)
  • Number of Patients Showing Pleural Effusion(1 day after the end of surgery)
  • Patient Demographic Data(on the day of admission)
  • Number of Patients Defined as Acute Respiratory Distress Syndrome(up to 7 days after the end of surgery)
  • Intraoperative Lung Compliance (ml/cmH2O)(every 1 hour from the time of the tracheal intubation to the end of the skin closure.)
  • Number of Patients Showing Postoperative Desaturation(up to 1 day after surgery completed)
  • Number of Patients Requiring Postoperative Re-intubation(up to 1 day after surgery completed)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyungseok Seo

Clinical Associate Professor

Kyung Hee University Hospital at Gangdong

研究点 (1)

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