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临床试验/NCT03469323
NCT03469323Unknown不适用

Can Mini-dose Succinylcholine Accelerate Lung Collapse and Intrathoracic Nerve Blocks During Nonintubated Thoracoscopic Surgery? A Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Quality of lung collapse

研究概览

简要总结

A safe and effective surgical environment is important for nonintubated thoracoscopic surgery. The investigators hypothesize that mini-dose succinylcholine can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery.

详细描述

Background: Nonintubated thoracoscopic surgery is the frontier of modern minimal invasive thoracic surgery. A safe and effective surgical environment is established via an iatrogenic open pneumothorax producing the operated lung fully collapsed. However, the initial respiratory response to open pneumothorax is both tachypnea and carbon dioxide rebreathing, which would jeopardize the quality of collapse of the operated lung and delay the performance of intrathoracic vagal block. Intravenous opioid is effective to attenuate ventilatory responses but herein with risk of persistent respiratory depression.

Methods: The investigators hypothesize that mini-dose succinylcholine 0.15 mg/kg can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery. In a prospective, randomized, double-blind study design, 30 patients will be allocated to receive either succinylcholine (n=15) or placebo (n=15) in the beginning of open pneumothorax. The effectiveness of succinylcholine will be measured by the surgeon's evaluation of the quality of lung collapse, while the safety will be evaluated by determination of arterial blood gases within 20 minutes of one-lung spontaneous breathing.

Expected results: Mini-dose succinylcholine can facilitate early lung collapse without jeopardizing the ventilatory function during nonintubated thoracoscopic surgery with one-lung spontaneous breathing, which may make nonintubated thoracoscopic surgery easier and safer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Adults patients with lung tumors and elective for unilateral thoracoscopic surgery.

排除标准

  • Over weighted, body mass index > 26 kg/m
  • Previous thoracic surgery on the attempted operative side.
  • Hypoventilation syndrome requiring positive pressure ventilatory support or oxygen at home.
  • Relevant systemic disease, including heart failure, liver failure, renal failure with an American Society of Anesthesiologists (ASA) class above
  • Difficult airway management.
  • Pregnancy.
  • Contraindications for succinylcholine, including family history of suspicious malignant hyperthermia, hyperkalemia, or other neuromuscular diseases.

研究组 & 干预措施

Nonintubated VATS succinylcholine

Experimental

Nonintubated VATS using mini-dose succinylcholine in the beginning of open pneumothorax

干预措施: Succinylcholine (Drug)

Nonintubated VATS placebo

Placebo Comparator

Nonintubated VATS not using succinylcholine in the beginning of open pneumothorax

干预措施: Placebo (Drug)

结局指标

主要结局

Quality of lung collapse

时间窗: 20 minutes

Quality of lung collapse will be quantified by the surgeon as score 1-3.

次要结局

  • Arterial blood gas analysis(20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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