Effect of Systemic Lidocaine Infusion on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Optic Nerve Sheath Diameter (ONSD)
研究概览
简要总结
We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation.
详细描述
Lidocaine use, both intravenous (IV) and laryngotracheal (LT), has been reported to blunt the ICP elevations during intubation. Also, Lidocaine injected IV has been shown in models to induce cerebral vasoconstriction leading to a decrease in cerebral blood volume and thus ICP. Furthermore, IV lidocaine leads to sodium channel inhibition and thus a reduction in cerebral activity and metabolic demands, as well as excitotoxicity, leading to a potential ICP reduction effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 35 to 65 years
- •American society of anesthesiology (ASA) physical status I - II
- •Body mass index (BMI) between 18.5 to 28.0 kg/m2
- •Scheduled for total laparoscopic hysterectomy taking approximately 2 h with a 30° Trendelenburg position for management of uterine fibroids or refractory dysfunctional uterine bleeding.
排除标准
- •Patients with eye diseases, central nervous system diseases, cardiovascular diseases, cerebrovascular diseases or diabetes.
- •If these events occurred intraoperative:
- •Ultrasound scans or measurements failed to clearly show the structure of Optic Nerve Sheath Diameter (ONSD).
- •Surgical time less than 1 h.
- •Interruption of carbon dioxide (CO2) pneumoperitoneum and Trendelenburg position.
- •Peak airway pressure exceeding 35 cm H2O
- •Patients with a history of allergy to lidocaine.
研究组 & 干预措施
Lidocaine group
Intravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation.
干预措施: Lidocaine (Drug)
Control group
Intravenous sodium chloride 0.9% solution volume matched in bolus and infusion.
干预措施: sodium chloride 0.9% solution (Drug)
结局指标
主要结局
Optic Nerve Sheath Diameter (ONSD)
时间窗: 5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum
ONSD at 5 min before induction of anesthesia in supine position (T1), 5 min after CO2 pneumoperitoneum in Trendelenburg position (T2), 30 min after CO2 pneumoperitoneum in Trendelenburg position (T3), 60 min after CO2 pneumoperitoneum in Trendelenburg position (T4) and 5 min after the closure of pneumoperitoneum in supine position (T5).
次要结局
- Heart rate(5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum)
- Mean arterial blood pressure(5 min before induction of anesthesia till 5 min after the closure of pneumoperitoneum)
- The incidence of postoperative adverse reactions(Within 3 hours after surgery)
研究者
Osama Rehab
Lecturer of Anesthesiology, Intensive Care and Pain Medicine
Tanta University