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临床试验/NCT02436954
NCT02436954Unknown不适用

Impact of Neuromuscular Blockade on Cerebral Oxygen Saturation in Laparoscopic Surgery Employ Carbon Dioxide-pneumoperitoneum

Konkuk University Medical Center0 个研究点目标入组 40 人开始时间: 2021年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
regional cerebral oxygen saturation 2

研究概览

简要总结

While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to achieve "optimal surgical space condition".

this difference in the pressure of intra-abdominal CO2 insufflation due to different strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in patient's respiratory pattern and cerebral oxygenation. Although previous study (studies) showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and cerebral oxygenation, so far.

The present study determines and compares the changes CO2 absorption and cerebral oxygenation (cerebral perfusion) after applying CO2 insufflation with different intra-peritoneal pressure 8 vs 12 mmHg during deep-NMB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • cholecystitis
  • provision of written informed consent

排除标准

  • low LV ejection fraction

结局指标

主要结局

regional cerebral oxygen saturation 2

时间窗: 2 min

2 min after the initiation of pneumoperitonium

regional cerebral oxygen saturation 1

时间窗: 1 min

1 min after the initiation of pneumoperitonium

regional cerebral oxygen saturation 3

时间窗: 3 min

2 min after the initiation of pneumoperitonium

次要结局

  • end-tidal carbon dioxide 2(2 min)
  • end-tidal carbon dioxide 3(3 min)
  • repiratory rate(3 min)
  • end-tidal carbon dioxide 1(1 min)

研究者

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

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Konkuk University Medical Center

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