Effect of Pneumatic leg Compression on Post Induction hypotension in Adult Patients undergoing decompressive craniotomy surgeries in isolated Traumatic Brain Injury patients: A Randomised Controlled trial.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- Ankur Luthra
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the incidence of ‘post induction hypotension’ after induction in the patients undergoing “decompressive craniotomy surgery†between the pneumatic and control groups
研究概览
简要总结
Pneumatic leg compression which is a simple, non-invasive technique has been shown to reduce the incidence of post-induction hypotension in surgeries like caesarean section (post-spinal anaesthesia) and robot-assisted laparoscopic prostatectomy. Although there is theoretical justification and some initial data in favour of the advantages of pneumatic leg compression, there is still a lack of thorough assessment via randomised controlled trials in the context of decompressive craniotomy surgeries. The purpose of this research is to evaluate the safety and effectiveness of pneumatic leg compression as a strategy to lower Post Induction Hypotension (PIH) and enhance patient outcomes in adult patients having isolated traumatic brain injury undergoing decompressive craniotomy surgery. We hypothesize that using pneumatic leg compression in isolated traumatic brain injury patients undergoing decompressive craniotomy surgeries both prior to and during the induction of general anaesthesia would decrease the incidence of post-induction hypotension, which is defined as systolic arterial pressure (SBP) of less than 90 mmHg at any time point in the first 20 minutes after induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •90 ASA I, II and III patients aged between 18-65 years having isolated severe traumatic brain injury i.e midline shift of ≥5mm and effacement of cisterns in CT scan, scheduled for decompressive craniotomy will be enrolled in this study.
排除标准
- •Uncontrolled hypertension and coronary artery disease, history of DVT, patient refusal, poor ejection fraction.
结局指标
主要结局
To compare the incidence of ‘post induction hypotension’ after induction in the patients undergoing “decompressive craniotomy surgery†between the pneumatic and control groups
时间窗: 20 minutes after induction of Anaesthesia
次要结局
- • Number of hypotensive episodes in first 20 mins after induction and post decompression craniotomy till end of surgery.(First 20 min after anaesthesia induction and decompressive craniotomy procedure)
- Use of vasopressors and, intravenous fluids etc. in first 20 minute and thereafter during surgery.(First 20 minutes after anaesthesia induction and then throughout the duration of surgery)
- Arterial blood gas changes between the baseline, 20 minutes post induction and at the end of the surgery in terms of base deficit, lactate and p/f ratio.(Baseline before anaesthesia induction, 20 minutes post induction of anaesthesia and at the end of surgery.)
- Observe the incidence of complications/side effects of the use of pneumatic compression device(Every 8 hours till 72 hours post surgery)
研究者
VIDUSHI AHLAWAT
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH