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临床试验/NCT04058106
NCT04058106撤回不适用

The Effect of Propofol Based Total Intravenous Anesthesia for Neuromonitoring on the Intraoperative Water Homeostasis in in Spine Surgery

Gangnam Severance Hospital1 个研究点 分布在 1 个国家开始时间: 2019年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
The water homeostasis changes of patients during propofol based total intravenous anesthesia for neuromonitoring in spine surgery

研究概览

简要总结

Previous study reported that propofol binded to glutamate receptors in the hypothalamus and inhibits AVP release mediated by endogenous γ-aminobutyric acid, as well as directly inhibits the regulated calcium currents leading to normal neuronal depolarization and AVP release. However, there is no clinical data demonstrating the mechanism of propofol can induce transient DI by inhibiting the release of AVP from the hypothalamus when applied to humans. Remifentanil, binding to the μ-receptor or partly κ-receptor, have been used in total intravenous anesthesia combined with propofol, also reported inhibiting AVP relaese in both the hypothalamus (κ receptor mediator mechanism) and posterior pituitary (μ receptor mediator mechanism). However, the effects of anesthetics on water homeostasis during surgery have been not well established. Therefore, we aim to investigate the changes of intraoperative water homeostasis, and related hormones and osmolality in patients with propofol based total intravenous anesthesia due to neuromonitoring for spine surgery.

详细描述

"All patients will get the total intravenous anesthesia with propofol-remifentanil via an effective site-controlled infusion (TCI). For this, TCI continuous infusion pump will be used with Schnider pharmacokinetic model for propofol and Minto pharmacokinetic model for remifentanil. Propofol and remifentanil will be initiated with target effective site concentrations of 3 μg.ml-1 and 3 ng.ml-1, respectively, and controll these concentrations considering patient's consciousness loss and vital signs. And then 0.6 mg kg-1 rocuronium for muscle relaxation will be administered for intubation. Anesthesia will be maintained with BIS level 40-60 and vital signs will not be more than 20% of the baseline or less. In order to prevent the sudden movement of the patient during surgery, rocuronium will be infused continuously about 50% of TOF until the end of intraoperative neuromonitoring.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients, ASA Classification I-Ⅲ between 20 and 70 years, scheduled the neuromonitoring for spine surgery in department of neurosurgery

排除标准

  • Taking thiazide/ACEi /ARB for hypertension
  • Receiving insulin treatment due to diabetes mellitus
  • Diagnosed with kidney disease or GFR < 60
  • Diagnosed with liver disease or AST/ALT > 100
  • Receiving furosemide or mannitol before surgery
  • DI was diagnosed before surgery or having polyuria
  • Taking lithium or antibiotics that are known to cause DI
  • Do not understand Korean language
  • Vulnerable subjects who are unable to obtain consent forms

结局指标

主要结局

The water homeostasis changes of patients during propofol based total intravenous anesthesia for neuromonitoring in spine surgery

时间窗: The change over time during surgery: baseline (before operation, T1), one hour after operation (T2), two hours after operation (T3), and three hours after operation (T4) - measure at four times

The amount of urine (polyuria standard\> 5 ml/kg/h) during surgery

次要结局

  • Postoperative polyuria (or diabetes insipidus)(At postoperative 24 hours and 48 hours)

研究者

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

Myoung Hwa Kim

Department of Anesthesiology and Pain Medicine

Gangnam Severance Hospital

研究点 (1)

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