Effect of Sugammadex in Wakeup Procedure
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
- 是
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
At the wakeup status Sugammadex 2 mg/kg single dose will perform.
干预措施: Sugammadex (Drug)
Neostigmine
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
ebru biricik
Anesthesiologist
Cukurova University
