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临床试验/NCT04174222
NCT04174222已完成不适用

The Effect of Deep Neuromuscular Blockade During Robotic Assisted Radical Prostatectomy on Intraoperative Respiratory Mechanics and Postoperative Pulmonary Complications : a Prospective Randomized Controlled Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Peak inspiratory pressure

研究概览

简要总结

This study is a randomized, controlled, double-blinded, and parallel design study. A total 58 patients were randomized to receive a deep block or a moderate block scheduled for elective robot assisted laparoscopic radical prostatectomy. Intraoperative peak inspiratory pressure and plateau pressure are assessed.

详细描述

Patients >18 years of age with an america society of anesthesiologist classification of I or II who are scheduled to undergo elective robot assisted laparoscopic radical prostatectomy are included. The exclusion criteria are a history of neuromuscular, renal, or hepatic disease, known allergy to rocuronium or sugammadex. Patients are randomized to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0). In the operating room, routine monitoring is performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry. Additionally, acceleromyography are applied to monitor the response of the adductor pollicis muscle. After the induction of anesthesia with propofol and before rocuronium administration, the TOF-Watch-SX is calibrated and stabilised, and a series of train-of-four (TOF) measurements are documented every 1 min. Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation. Anesthesia is maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index. Intravenous rocuronium (5-10 mg) is used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade. Peak inspiratory pressure and plateau pressure are recorded until 1 hour after pneumoperitoneum. At the end of the operation, the surgeon rated the surgical condition on a 5-point scale. Patients are reversed with intravenous sugammadex at 2 or 4 mg/kg. Postoperative pulmonary complications (SpO2 <100%, RR<8, atelectasis) are assessed and recorded.

研究设计

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

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Patients who undergo elective robot assisted radical prostatectomy,
  • •American Society of Anesthesiologists grade 1 or 2

排除标准

  • •Refuse to participate to the study
  • •history of neuromuscular diseases
  • •known allergy to rocuronium, sugammadex
  • •patients scheduled for intensive care unit transfer
  • •Body Mass Index > 30 kg/m2
  • •Severe renal function impairment
  • •Moderete or severe obstructive/restrictive lung disease

研究组 & 干预措施

Moderate block

Active Comparator

5-10mg rocuronium is administered to maintain train-of-four count 1-2. At the end of surgery, sugammadex 2mg/kg is administered IV for reversal of neuromuscular block.

干预措施: Moderate NMB (Other)

Deep block

Experimental

5-10mg rocuronium is administered to maintain train-of-four count 0, and post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block

干预措施: Deep NMB (Other)

结局指标

主要结局

Peak inspiratory pressure

时间窗: until 1 hour after pneumoperitoneum

measured through ventilator

次要结局

  • dynamic lung compliance(until 1 hour after pneumoperitoneum)
  • 5-point surgical rating scale(1 min at the end of surgery)
  • Postoperative pulmonary complications(postoperative 30 min)
  • plateau pressure(until 1 hour after pneumoperitoneum)
  • static lung compliance(until 1 hour after pneumoperitoneum)

研究者

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

Chang-Hoon Koo

Assistant professor

Seoul National University Hospital

研究点 (1)

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