Förekomsten av trötthet Vid Neurokirurgisk Vakenkirurgi
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
- 否
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
