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临床试验/NCT02057861
NCT02057861已完成不适用

The Comparison of Reversal of Neuromuscular Blockade in Diabetic and Non-Diabetic Patients

Duzce University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
reversal of diabetic patients

研究概览

简要总结

In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.

详细描述

Aim: In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.

Methods: Included patients were divided into 2 groups: diabetic (n=21) and non-diabetic (n=20). All patients were premedicated. After arrival in the operating room, all patients were monitorised with Datex Ohmeda S/5 Anesthesia Machine and electrocardiography (DII derivation), hemodynamic variables, respiratory rate, and inspiratory sevoflurane concentrations were recorded. Neuromuscular monitoring system was used. Anesthesia was induced with propofol 2 mg/kg and fentanyl 1 mcg/kg. After the loss of eyelid reflex the neuromuscular monitoring system automatically identified supramaximal stimulating currents and after that rocuronium 0,6 mg/kg was given. Train of four (TOF) stimulation with the supramaximal current were applied and by recording of second TOF value (TOF2) the patient was intubated. Anesthesia was maintained with 50% O2 + 50% air and sevoflurane of 1-2 % concentration. TOF stimulation was applied and recorded every 20 seconds. Intraoperatively by return T2 rocuronium 0,15 mg/kg was given. T2i time was recorded as intubation time and T2d time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was given. When TOF rate reached 0,9 patients were extubated and the time was recorded.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients (diabetic and non-diabetic) between 18-65 years with risk of anesthesia I-II,
  • For diabetic group patients with Diabetes mellitus Type 2 over 10 years.
  • For non-diabetic group patients without any glucose metabolism disease

排除标准

  • myasthenia gravis, myotonic dystrophia, motor neuron diseases
  • diabetic neuropathy and nephropathy
  • hepatic, renal and cardiac diseases

结局指标

主要结局

reversal of diabetic patients

时间窗: 24 hours

T2i time was recorded as intubation time and T2d time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was given. When TOF rate reached 0,9 patients were extubated and the time was recorded.

次要结局

  • hemodynamic changes(24 hours)

研究者

发起方
Duzce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

yavuz demiraran

Professor Doctor

Duzce University

研究点 (1)

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