Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Thiopentone requirement
研究概览
简要总结
This study was conducted in two parts:
- This first part was designed to determine thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index monitoring - Participant and Care Provider in appropriate study arm blinded.
- As a secondary outcome, Bispectral index monitoring was used to observe changes in neuronal function in intraoperative period as well as haemodynamic changes intraoperatively - Participant and Care Provider blinded.
详细描述
Surgery for traumatic brain injury is an anaesthetic challenge fraught with complications such as brain bulge, excessive bleeding, hypotension etc. As yet there are no anaesthetic regimen guidelines to follow for induction of anaesthesia in neurotrauma surgeries. Although the functional effect of anaesthetic agents on neuronal tissue is known quite well, there is lack of studies documenting the effect of these anaesthetic agents on head injured patients. It is also not known whether the requirement of anaesthetic agent in the same as a non head injured patient. This study was designed to assess the requirement of anaesthetic thiopentone in head injured patients and compare the anaesthetic usage with and without Bispectral index (BIS) monitoring. We also observed the real time change in neuronal function using Bispectral Index monitoring after craniotomy, i.e. effectively decompression and release of intracranial pressure intraoperatively.
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
- Double (Participant, Care Provider)
盲法说明
- Anaesthetic care provider in one arm of first part of study was blinded to intraoperative changes in Bispectral index.
- Anaesthetic care provider was blinded to Bispectral Index changes in second part of study.
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
- 否
入选标准
- •Head injury patients coming for surgery
排除标准
- •Hypotension/Arrythmias at time of induction
- •Extra Dural Hemorrhage
- •Extracranial injuries
- •Scalp lacerations
- •History of Seizures
- •No consent
研究组 & 干预措施
Group BIS
Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.
干预措施: Bispectral Index (Device)
Group Clinical
Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.
结局指标
主要结局
Thiopentone requirement
时间窗: Beginning of anaesthetic induction till End of anaesthetic induction
Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.
次要结局
- Intraoperative Bispectral Index changes(Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.)
- Intraoperative Systolic blood pressure changes(Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.)
- Intraoperative Mean blood pressure changes(Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.)
- Intraoperative heart rate changes(Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.)
研究者
Dhritiman Chakrabarti
Assistant Professor
National Institute of Mental Health and Neuro Sciences, India