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临床试验/NCT06922487
NCT06922487招募中不适用

Förekomsten av trötthet Vid Neurokirurgisk Vakenkirurgi

Region Skane1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
10
试验地点
1
主要终点
Change in KSS

研究概览

简要总结

Occasional patients with intracranial tumors need to have a planned awakening during surgery to avoid major disability from the tumor resection. During the awake part of the surgery an increasing degree of tiredness is observed. For the surgeon to plan the resection knowledge of the degree and speed of tiredness/sleepiness evolution is important.

The goal of this single center study is to use the "Karolinska Sleepiness Scale" during and after awake surgery for neurosurgical tumor resection to quantify the time available for surgical intervention.

Participants are adults having planned surgery for open resection of intracranial tumor with a planned awakening for assessment during surgery. Participants will be asked to grade postoperative sleepiness using the "Karolinska Sleepiness Scale".

详细描述

Background The incidence of primary tumors in the central nervous system in adults in Sweden is approximately 1400 per year. Gliomas constitutes the most common form, approximately 50%. The neurosurgery aims at securing material for pathological-anatomical diagnosis, reduction of symptoms, maximal reduction of tumor mass with minimal functional impact. Occasional patients present with tumors in sensitive areas necessitating operation with the patient awake and co-operable to optimize the resection. The procedure is typically performed as an asleep-awake-asleep procedure. A clinical observation is that the patients tend to become increasingly sleepy/tired during resection. This study aims to quantify this phenomenon.

Methods Ethical review board approval (Dnr 2024-01935-01, Stockholm, Sweden) is present.

The study is a single center kohort study.

Participants will be identified by the neurosurgeon planning tumor resection with intraoperative awake surgery. Inclusion and information are given preoperatively by the neurosurgeon and the anesthetist.

All participants receive propofol/remifentanil based general anesthesia with norepinephrine infusion to support blood-pressure during preparation and craniotomy whereafter the participant is awakened. The resection starts when the participant is coherent and cooperative. Peroperative level of sedation is assessed using Karolinska Sleepiness Scale (KSS) every 15 minutes. KSS is an ordinal nine grade scale assessing sleepiness during the last five minutes from "extremely alert" to "very sleepy, great effort to keep awake, fighting sleep". When the resection is completed the participants receives general anesthesia during wound closure. Postoperative level of sedation is assessed using Karolinska Sleepiness Scale (KSS) during the first two postoperative hours.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (>18 years old)
  • Elective supra or infratentorial tumor resection via craniotomy
  • Surgical need for awake surgery
  • Cognitive function allowing informed consent.

排除标准

  • Tumor resection without awake surgery
  • Morbid obesitas

结局指标

主要结局

Change in KSS

时间窗: during surgery and 2 hours postoperatively

Change in KSS during resection

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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