跳至主要内容
临床试验/NCT06922500
NCT06922500招募中不适用

Anesthetic Depth Assessed by Processed EEG (pEEG) - a Comparison of Manual Total Intravenous Anesthesia and Target Controlled Anesthesia in Tumor Resection Via Craniotomy

Region Skane1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
126
试验地点
1
主要终点
Amount of time during anestehsia and surgery within recommended levels of processed EEG (pEEG)

研究概览

简要总结

An important feature of neurosurgical anesthesia is early postoperative recovery of consciousness with minimal residual sedation. This is a key factor to enable early neurological assessment and early discovery of postoperative complications.

The goal of this single centre clinical trial is to compare propofol/remifentanil anesthesia delivered by manual total intravenous anesthesia (mTIVA) or target controlled infusion (TCI) for intracranial tumor resection via craniotomy. Anesthetic depth will be assessed by a simplified processed EEG (pEEG).

The main question is time spent within recommended pEEG- levels from anesthesia induction until end of surgery.

Secondary questions are:

  • mean pEEG-level, time from end of surgery to consiousness,
  • peroperative propofol/remifentanil consumption
  • postoperative degree of sleepiness
  • awareness assessment

Participants are adults having have planned surgery for open resection of a brain tumor and will receive general anesthesia with propofol and remifentanil randomized to mTIVA or TCI. pEEG vill be blinded.

  • Participants will be asked to grade postoperative sleepiness using a specific scale
  • Follow up regarding awareness will be performed.

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. An important feature of neurosurgical anesthesia, apart from intraoperative stability, is early postoperative recovery of consciousness with minimal residual sedation. This is a key factor to enable early neurological assessment and early discovery of postoperative complications (hematomas).

In total intravenous anesthesia the anesthesia drugs (e.g. propofol and remifentanil) are supplied by continuous intravenous infusion. The pumps used for administration can be programmed manually (in mg/kg/h or mcg/kg/min, manual total intravenous anesthesia, mTIVA) or using a programmed algorithm (target controlled infusion, TCI, where the algorithm calculates the concentration of drug at the effect site). Regardless of programing system, the anesthetist or anesthetic nurse adjusts the programming to the patients´ needs during anesthesia and surgery. The Neurosurgical anesthesia section of Lund University Hospital, Lund, Sweden, uses both mTIVA and TCI and all exposed anesthetic personnel are comfortable with both mTIVA and TCI.

Montoring of anesthetic depth is based on physiological reactions. In neurosurgical anaesthesia access to face and pupils are restricted/absent and thus monitoring further restricted. To add to the monitoring of anesthetic depth several processed simplified EEG systems (pEEG) have been developed. EEG systems have proprietary underlying algorithms and are thus not directly comparable. The recommendations regarding adequate anesthesia dept differs considerably numerically. pEEG -systems are expected to add to the evaluation of anesthetic depth, reduce the risk of awareness and reduce the risk of over- anesthetizing with hypotension and prolonged recovery of consciousness during emergence. pEEG has predominantly been assessed in other subspecialities than neuroanesthesia. In neuroanesthesia interference of the pEEG monitoring system with the surgical field is one factor that has to be taken into account when placing the monitoring system, especially in frontally placed tumors.

Bispectal index (BIS, Medtronic,) is one of several commercially processed EEG systems (pEEG). BIS is a pEEG index ranging from 0-100, where 0 corresponds to isoelectric EEG and 100 to full alertness. Recommended anesthesia depth is 40-60 intraoperatively. The EEG-monitoring in the BIS system is available as a unilateral strip increasing clinical usefulness in this setting.

The aim of this study is to improve anaesthesia and monitoring for intracranial tumor resection by evaluating the effect of pEEG monitoring for propofol/remifentanil anesthesia delivered by manual total intravenous anesthesia (mTIVA) or target controlled infusion (TCI).

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • •Elective craniotomy for tumor resection
  • •Adult patient
  • •Consent to participation

排除标准

  • •Cognitive impact affecting infrmed consent
  • •brain tumor planned for biopsy without resection Tumor localisation not permitting placement of pEEG electrodes.

研究组 & 干预措施

TIVA

Active Comparator

propofol and remifentanil anesthesia using traditional total intravenous anestesia (mg/kg/min)

干预措施: depth of anesthesia (Device)

TCI

Active Comparator

Propofol and remifentanil anestesia using target controlled anestesia

干预措施: depth of anesthesia (Device)

结局指标

主要结局

Amount of time during anestehsia and surgery within recommended levels of processed EEG (pEEG)

时间窗: During anesthesia

Prior to induction processed EEG (pEEG) will be applied. The pEEG result will not be available to anesthetic personel during surgery. Patients will be anestetised using TIVA or TCI (propofol/remifentanil). Primary endpoint is time within recommended levesl of pEEG.

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)

Loading locations...

相似试验