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临床试验/NCT03910556
NCT03910556已完成不适用

Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study

Chiang Mai University0 个研究点目标入组 439 人开始时间: 2017年1月最近更新:
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
439
主要终点
re-craniotomy

研究概览

简要总结

This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.

详细描述

Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation.

Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation.

Postoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are scheduled for elective craniotomy during 2017-2019
  • Patients who are planned for general anesthesia
  • Patients have read the study information and signed in the consent form

排除标准

  • Patients who are unable to understand and sign in the consent form
  • Patients who are scheduled for minor surgical procedures such as ventriculostomy and VP-shunt

研究组 & 干预措施

no complication

the patients who did not develop any kind of complication and no re-craniotomy

干预措施: Propofol (Drug)

with complication (s)

the patients who developed at least one of non-neurological complication or required re-craniotomy

干预措施: Propofol (Drug)

结局指标

主要结局

re-craniotomy

时间窗: the first 24 hours

number of participants who required re-craniotomy assessed by the neurosurgeon

predictive factors of re-craniotomy

时间窗: the first 24 hours

types of perioperative factors to predict the occurrence of re-craniotomy

次要结局

  • incidence of major non-neurological complications(the first 24 hours)
  • predictive factors of major non-neurological complications(the first 24 hours)

研究者

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

Pathomporn Pin on, M.D.

Assistant Professor

Chiang Mai University

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