The Effect Of Total Intravenous Anesthesia And Inhalational Anesthesia On The Markers Of Neuronal And Systemic Inflammation In Patients Undergoing Resection Of Supratentorial Gliomas: A Prospective Randomized Controlled Trial â€
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Changes in the blood level of neuron specific enolase measured before induction of anesthesia & at the end of surgery
研究概览
简要总结
This study intends to evaluate which anaesthetic technique, propofol-based total intravenous anesthesia or sevoflurane-based inhalational anesthesia has a better neuronal and systemic anti-inflammatory profile. Glioma is a disease state with a high risk of morbidity and mortality. Thus, identifying the ideal anaesthetic agent will provide a better neurophysiological profile by suppressing neuronal and systemic inflammation in the perioperative period. A prospective randomized controlled trial will be done to evaluate the inflammatory markers in patients undergoing craniotomy for supratentorial glioma under propofol-based intravenous anaesthesia and sevoflurane-based inhalational anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient consent 2) ASA class I-II 3)Age 18-65 years, undergoing craniotomy for supratentorial glioma in the neurosurgery operation theatre 4)Preoperative Karnofsky Performance Scale of 70 or above.
排除标准
- •ASA class III,IV, V 2) Severe or uncompensated cardiovascular, renal, hepatic or endocrine disease 3) Pregnancy, postpartum and lactating females 4) Drug allergy to Propofol 5) Refusal to consent by patient or next of kin •patients with an active inflammatory process such as infection or immunologic illness known to increase the baseline immunologic markers, •Emergency surgery •Revision craniotomy at the same site •Preoperative history of seizures.
- •â€¢ h/o preoperative cognitive dysfunction.
结局指标
主要结局
1.Changes in the blood level of neuron specific enolase measured before induction of anesthesia & at the end of surgery
时间窗: Before induction of anesthesia & after extubation
2.Changes in the blood level of interleukin -6 measured before the induction of anesthesia & at the end of surgery
时间窗: Before induction of anesthesia & after extubation
次要结局
- Hemodynamic parameters- heart rate & invasive blood pressure, urine output, maximum allowable blood loss, estimated blood loss, & total fluid input.(1)Tumour type, size, location, grade of tumor, duration of surgery, duration of anaesthesia, days of ICU stay, and days of hospital stay.)