Effect of Two Cut-Off Values of Plethysmographic Variability Index to Guide Intraoperative Fluid Therapy on Serum Lactate in Patients Undergoing Excision of Supra-Tentorial Brain Tumors: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Serum lactate level
研究概览
简要总结
This study aimed to compare two cut-off values of plethysmographic variability index (PVI) -guided fluid therapy in patients undergoing supra-tentorial mass excision regarding immediate postoperative serum lactate.
详细描述
Fluid therapy in patients undergoing craniotomy is very critical; hypovolemia might decrease cerebral perfusion, while fluid overinfusion might cause brain swelling that impairs surgical removal of lesions.
The plethysmographic variability index (PVI) is one of the dynamic indices of fluid responsiveness, a simple, automatic, non-invasive, and continuous method based on calculating changes in the perfusion index (PI).
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, 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
- •Age above 18 years old.
- •Both sexes.
- •Patients scheduled for supra-tentorial brain tumor excision.
排除标准
- •Arrhythmias.
- •Pulmonary hypertension.
- •Impaired cardiac contractility.
- •Impaired liver or kidney function.
- •Low lung compliance.
- •Body mass index above
- •Intra-operative hemodynamic instability on vasopressors or inotropes.
- •Peripheral arterial occlusive diseases.
- •Hand injuries or burns that preclude the application of the Masimo device probe.
研究组 & 干预措施
Low PVI group
Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 14%.
干预措施: Fluid Therapy (Other)
High PVI gro
Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 20%.
干预措施: Fluid Therapy (Other)
结局指标
主要结局
Serum lactate level
时间窗: 24 hours postoperatively
Serum lactate level was measured at the end of surgery (immediately after extubation).
次要结局
- Brain Relaxation scale(Intraoperatively)
- Heart rate(20 minutes after fluid loading)
- Mean arterial pressure(20 minutes after fluid loading)
- Length of hospital stay(Till discharge from the hospital (Up to 2 weeks))
研究者
Abdelrahman Gomaa Abdelhameed Eltokhy
Assistant Lecturer of Anesthesia, Pain Management and surgical ICU, Faculty of Medicine, Cairo University, Cairo, Egypt.
Cairo University