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临床试验/NCT02185339
NCT02185339已完成4 期

Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study

Seoul St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
61
试验地点
1
主要终点
Thoracopulmonary Compliance

研究概览

简要总结

The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I or II patients scheduled to undergo laparoscopic renal surgery

排除标准

  • BMI ≥35 kg/m2
  • Known neuromuscular disease
  • History of chronic obstructive pulmonary disease
  • Pneumothorax
  • Bronchopleural fistula
  • Previous lung surgery
  • Previous retroperitoneal surgery
  • Hemodynamic instability
  • History of cardiopulmonary disease
  • Renal insufficiency

研究组 & 干预措施

dNMB group

Experimental

For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.

干预措施: Rocuronium (Drug)

mNMB group

Active Comparator

For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count >2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.

干预措施: Rocuronium (Drug)

结局指标

主要结局

Thoracopulmonary Compliance

时间窗: intraoperative

Was measured with a patient spirometry monitor through a flow sensor. Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).

次要结局

  • Arterial Oxygen Tension/Inspired Oxygen Fraction(intraoperative)
  • Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference(intraoperative)
  • Estimated Dead Space(intraoperative)
  • Pulmonary Shunt(intraoperative)

研究者

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

Sanghyun Hong

Assistant professor

Seoul St. Mary's Hospital

研究点 (1)

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