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临床试验/NCT03521414
NCT03521414已完成不适用

The Effect of Glasgow Coma Scales on General Anesthesia in Neurosurgery Patients

Trakya University0 个研究点目标入组 45 人开始时间: 2013年7月3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
45
主要终点
BIS, Consumption of the inhalation agents

研究概览

简要总结

The study evaluates the general anesthesia management with BIS monitorization in terms of hemodynamic stability, drug concentrations and drug consumption in patients who underwent surgery due to intracranial pathology and who were divided in three different GCS groups.

详细描述

BIS monitoring is mostly used for anesthesia depth and sedation level follow-up, however it can also be used for monitoring consciousness after resuscitation of cases with acute brain injury and cardiac arrest. It is not always possible to monitor and objectively measure the changes in the level of consciousness in clinical practice. Therefore, device-based methods have been introduced in monitoring the state of consciousness. Bispectral index (BIS) monitoring may be preferred in follow up of the state of consciousness in critical patients such as those with acute brain injury, in terms of ease of use, ability to obtain numerical results and continuous monitoring. BIS monitoring is mostly used for follow up of anesthesia depth and sedation level, while it can also be applied for monitoring state of consciousness following resuscitation in cases with acute brain injury and cardiac arrest.In this study, we aimed to investigate general anesthesia management performed by bispectral index monitoring in patients who underwent surgery due to intracranial pathology and with different Glasgow Coma Scales.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 and 65 years
  • ASA II-III
  • intracranial surgery

排除标准

  • Patients with additional disease (electrolyte impairment, uremia, etc.),
  • liver and renal failure affecting consciousness level other than intracranial pathology

研究组 & 干预措施

Group I=13-15 mildly injured

Active Comparator

Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative.

Group I (n=15)=13-15 mildly injured

干预措施: Bispectral index (BIS) monitoring (Device)

Group I=13-15 mildly injured

Active Comparator

Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative.

Group I (n=15)=13-15 mildly injured

干预措施: Sevoflurane (Drug)

Group 2 =9-12 moderately damaged

Active Comparator

Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery.use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative.

Group 2 (n=15)=9-12 moderately damaged

干预措施: Bispectral index (BIS) monitoring (Device)

Group 2 =9-12 moderately damaged

Active Comparator

Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery.use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative.

Group 2 (n=15)=9-12 moderately damaged

干预措施: Sevoflurane (Drug)

Group 3=3-8 severely damaged.

Active Comparator

Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative.

Group 3 (n=15)=3-8 severely damaged.

干预措施: Bispectral index (BIS) monitoring (Device)

Group 3=3-8 severely damaged.

Active Comparator

Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative.

Group 3 (n=15)=3-8 severely damaged.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

BIS, Consumption of the inhalation agents

时间窗: 200 minutes

Preoperative, intraoperative and postoperative BIS values were recorded. The total amount of opioid consumed was recorded from the infusion pump.

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

Sevtap Hekimoglu Sahin

Director, clinical research

Trakya University

相似试验

Glasgow Coma Scales and General Anesthesia | 临床试验