A Comparative Study of Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The amplitude score of Somato sensory evoked potential
研究概览
简要总结
The objective of this study is to evaluate the effect of adding dexmedetomidine on evoked potentials in adult patients undergoing spinal surgery under intravenous anesthesia
详细描述
A catastrophic complication of spinal surgery is nerve and spinal cord injury. The incidence of neurological defects after spinal surgery can be reduced from 3.7%-6.9% to less than 1% with proper electrophysiological monitoring.
Somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) are currently used as adjunct diagnostic methods in spinal surgery, such as scoliosis surgery and spinal stenosis decompression.
Total intravenous anesthesia (TIVA) with propofol and opioids is commonly used in SEPs and MEPs monitoring as it causes increase in latency in comparison to inhalational anesthetics that cause decrease in amplitude .
The amplitudes of MEPs and SEPs are reduced by halogenated volatile anesthetics, limiting their use in spinal surgery that requires electrophysiological monitoring. When volatile anesthetics did not exceed 0.3MAC, they had little effect on MEPs and SEPs . Martin et al. discovered that volatile agent-based anesthesia has application value during neurophysiological monitoring, such as faster awakening and rapid wake-up tests.
As well, volatile anesthetics can reduce the dosage of propofol. As a result, spinal surgery benefits from combined intravenous inhalation anesthesia. As an adjuvant, dexmedetomidine may be useful in reducing the need for propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 21-45 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status II and III.
- •Undergoing major spine surgery
排除标准
- •Refusal of procedure or participation in the study by patients.
- •Patients with known history of allergy to one of study drugs
- •Patients with nerve conduction pathway injury.
- •Severe circulatory or respiratory disease.
- •Cognitive or psychiatric illness that leads to inability to cooperate, speak or provide informed consent
- •Patients with history of Myasthenia gravis, epilepsy , history of pacemaker implantation .
- •Patients who need to be awakened during the procedure.
研究组 & 干预措施
Group A (Propofol-Fentanyl)
Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery. Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation.
干预措施: Propofol-Fentanyl (Drug)
Group B (Propofol-Fentanyl-Dexmedetomidine)
Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery.
In addition patients will receive Dexmedetomidine (0.5ug.kg) loading dose infused over 10 mins followed by a constant infusion rate of (0.2ug/kg/hr). Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation.
干预措施: Propofol-Fentanyl-Dexmedetomidine (Drug)
Group C (Propofol-Fentanyl-Sevoflurane)
Anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 ug/kg). Anesthesia will be maintained with propofol and fentanyl infusion, commenced at 10 mg/kg/hr and 0.5 ug/kg/hr respectively and adjusted to keep BIS between 40 & 50 during surgery.
In addition the anesthesia will be maintained with inhalational anesthesia of 50% oxygen , 50% air plus sevoflurane concentration adjusted to keep BIS between 40 & 50 . Minimal dose of atracurium 0.1 mg/kg will be given at induction to facilitate intubation
干预措施: Propofol-Fentanyl-Sevoflurane (Drug)
结局指标
主要结局
The amplitude score of Somato sensory evoked potential
时间窗: 6 hours postoperatively
The amplitude score of the waveforms will be measured. More than 50% decrease in the amplitude and more than 10% prolongation of the latency of Compound muscle action potential ( CMAP) from the baseline values will be defined as significant
次要结局
- Intraoperative bleeding(Intraoperatively)
- The latency of Somato sensory evoked potential(6 hours postoperatively)
- The latency of motor evoked potential(6 hours postoperatively)
- The amplitude score of motor evoked potential(6 hours postoperatively)
- Intraoperative fentanyl consumption(Intraoperatively)
- Intraoperative propofol consumption(Intraoperatively)
- Intraoperative dexmedetomidine consumption(Intraoperatively)
- Intraoperative sevoflurane consumption(Intraoperatively)
- Changes in heart rate(Till the end of operation)
- Changes in mean arterial pressure(Till the end of operation)
- Quality of surgical field(Till the end of operation)
研究者
Mohamed Ibrahim ElSayed Shahin
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt
Ain Shams University