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临床试验/NCT02390817
NCT02390817已完成4 期

Effect of Sugammadex in Wakeup Procedure

Cukurova University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3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
60
试验地点
2
主要终点
Time to consciousness

研究概览

简要总结

The study will be performed to evaluate motor response and awareness with using sugammadex during wakeup procedure in spine surgery. The investigator's goal is to investigate the effect of sugammadex on the state of consciousness and motor-somatosensorial evoked potentials.

详细描述

Between 10-25 age, American Society of Anesthesiologist clinical status(ASA) I-II, 60 patient which will be performed spine surgery in orthopedics clinic will be enrolled in this study. Patient will be randomized into two group that include 20 patient. General anesthesia will be administered by Totally intravenous anesthesia (TIVA) with propofol and remifentanyl for all patients. Two groups will be monitored with BIS (bispectral index), TOF (train-of-for) MEP (motor evoked potential) and SSEP (somatosensorial potential). During wakeup procedure, in group S, TIVA will be stopped and 2 mg/kg of sugammadex will be given intravenously. BIS, TOF, MEP, SSEP will be measured. In group N, TIVA will be stopped and 0.04 mg/kg of neostigmine will be given. Also BIS, TOF, MEP, SSEP will be measured. Sugammadex will be given group S and Neostigmine will be given group N at the end of the operation. At postoperative sixth hour, the investigators will visit all the patients and ask standard questions about intraoperative wakeup procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • American society of anesthesiologists (ASA) physical status I-II patients
  • spine surgery
  • 10-25 age

排除标准

  • ASA III and above
  • Patient refusal
  • neuromuscular disease

研究组 & 干预措施

Sugammadex

Active Comparator

At the wakeup status Sugammadex 2 mg/kg single dose will perform.

干预措施: Sugammadex (Drug)

Neostigmine

Placebo Comparator

At the wakeup status Neostigmine 0,04 mg/kg single dose will perform.

干预措施: Neostigmine (Drug)

结局指标

主要结局

Time to consciousness

时间窗: 30 min

time to obeying verbal commands after reversal of NMBAs

次要结局

  • To assess Motor Evoked Potential values(4 hours)
  • To assess Somatosensorial Evoked Potential values(4 hours)

研究者

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

ebru biricik

Anesthesiologist

Cukurova University

研究点 (2)

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