跳至主要内容
临床试验/NCT05103735
NCT05103735已完成不适用

Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation

Azienda Sanitaria-Universitaria Integrata di Udine1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2021年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
SEIZURE ACTIVITY

研究概览

简要总结

Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters.

Neurosurgeon could be help by Intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. Propofol and remifentanyl have been largely used. Dexmedetomidine represents an alternative. However little is known about the role of dexmedetomidine on Intraoperative electrocorticography.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION (EXCLUDED E.G. SURGERY OF EPILEPSIA)
  • INTRAOPERATIVE MONITORING (IOM) WITH ELECTROCORTICOGRAPHY
  • AWAKE-AWAKE-AWAKE TECHNIQUE

排除标准

  • AGE <18 YEARS OLD
  • NON AWAKE-AWAKE-AWAKE TECHNIQUE
  • ABSENCE OF IOM

研究组 & 干预措施

PROPOFOL-REMIFENTANYL

Awake craniotomy under propofol-remifentanil sedation. Propofol and remifentanyl was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure.

Propofol dosage: 0.2-2 mk/kg/h Remifentanyl dosage: 0.01-0.1 mcg/kg/min

干预措施: Propofol (Drug)

结局指标

主要结局

SEIZURE ACTIVITY

时间窗: DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY

INCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.

次要结局

未报告次要终点

研究者

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

Cristian Deana

Principal Investigator

Azienda Sanitaria-Universitaria Integrata di Udine

研究点 (1)

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