Effect of Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Optic nerve sheath diameter
研究概览
简要总结
This study will be conducted to evaluate the effects of different anesthetic modalities [sevoflurane with or without intraoperative lidocaine infusion and Propofol total intravenous anesthesia (TIVA)] on intracranial pressure (ICP) and cerebral oxygenation assessed by non-invasive methods during laparoscopic hysterectomy (LH).
详细描述
Laparoscopic hysterectomy (LH) requires a Trendelenburg position (TP) and the creation of an artificial pneumoperitoneum (PP) by carbon dioxide insufflation.
Various studies were done to evaluate the effects of different anesthesia techniques on intracranial pressure (ICP) during LH, and most of these studies revealed that propofol total intravenous anesthesia (TIVA) was superior to inhaled anesthesia regarding reduction of ICP (ONSD).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •American Society of Anesthesiologists (ASA) physical status I and Ⅱ.
- •Body mass index (BMI) ≤
- •Females scheduled for laparoscopic hysterectomy.
排除标准
- •Patients' refusal to participate in the study.
- •Hypersensitivity and allergy to drugs of the study.
- •Contraindication for optic nerve sheath diameter assessment. E.g., patient with pre-existing ophthalmic diseases, a history of ophthalmic surgery
- •Any central nervous system or cardiovascular disease, severe hepatic or renal impairment
- •Intraoperative circumstances, such as inability to perform optic nerve sheath diameter or conversion to open surgery
- •If peak inspiratory pressure (PIP) exceeds 35.
研究组 & 干预措施
Propofol group
Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60.
干预措施: Propofol (Drug)
Sevoflurane plus lidocaine infusion group
Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery.
干预措施: Sevoflurane plus lidocaine infusion (Drug)
Sevoflurane group
Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Optic nerve sheath diameter
时间窗: After extubating the endotracheal tube (up to one hour)
Optic nerve sheath diameter of both eyes is expressed in millimeters and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP),T4; 60 minutes after PP and TP,T5; Five minutes after disinflation of PP and T6;after extubating the endotracheal tube.
次要结局
- Cerebral oxygenation(After extubating the endotracheal tube (up to one hour))
- Cognitive function(4 hours postoperatively)
- Incidence of postoperative complications(24 hours postoperatively)
研究者
Eman Ali Abd-Elsamea Elrefaey
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University