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临床试验/NCT01985854
NCT01985854Unknown4 期

Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery: A Pilot Study for Assessment of Recovery Parameters

Tokyo Women's Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Time from the discontinuation of anesthesia to extubation

研究概览

简要总结

Since neurological testing during neurosurgery, such as somato-sensory evoked potentials, motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well maintained their wave-form reactivity with total intravenous anaesthesia technique better than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the evoked potential responses during surgery, facilitation of recovery from general anesthesia is getting important, because the real neurological physical examination is much more sensitive than above electrical evoked potentials to evaluate the results of surgical operation.

We propose to evaluate the recovery parameters after conversion from total intravenous anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The conversion will be initiated upon completion of the neurophysiological electric evoked potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize that recovery after conversion to Desflurane will be faster compared to recovery after total intravenous anaesthesia alone.

研究设计

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

入排标准

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

入选标准

  • Patients undergoing elective craniotomy
  • American Society of Anesthesiology Physical Status Ⅰ, II and III
  • Age: between 20 to 65 years
  • Sex: male or female
  • Patients who are postmenopausal or surgically sterilized
  • Expected Operation time is longer than 4 hours.

排除标准

  • 未提供

研究组 & 干预措施

Propofol

Active Comparator

Propofol target-controlled infusion will be kept 2-4μg /ml plasma concentration throughout procedure.

干预措施: Propofol (Drug)

Desflurane

Experimental

After taking off the electrophysiological monitoring from the patients, discontinue propofol and start desflurane from 6% (dialed concentration) at flow rate of 4L/min for 2 minutes in desflurane group. When achieve end tidal concentration of 4-5%, decrease the flow rate to 2L/min.

干预措施: Desflurane (Drug)

结局指标

主要结局

Time from the discontinuation of anesthesia to extubation

时间窗: Patients will be followed in the operation room, an expected average of 30 minutes.

次要结局

  • Cognitive function(Up to 24 hours)
  • Time from the discontinuation of anesthesia to eye opening(At the end of surgery, duration time from the discontinuation of anesthesia to the eye opening will be measured, averaged expected time is 30 minutes)
  • Time from the discontinuation of anesthesia to orientation(Up to 24 hours)

研究者

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

Makoto Ozaki

Professor

Tokyo Women's Medical University

研究点 (1)

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