Effect of Dexmedetomidine-Ketamine vs. Propofol-Fentanyl Anaesthesia on Motor Evoked Potential Signal Acquisition During Cervical Lateral Mass Fusion in Patients with Cervical Myelopathy: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The primary outcome will focus on the MEP Amplitudes recorded from the Abductor Pollicis Brevis (APB), Tibialis Anterior (TA), Abductor Hallucis Longus (AHL), and Deltoid muscles
研究概览
简要总结
Cervical myelopathy is a progressive condition caused by spinal cord compression, often requiring surgical intervention such as cervical lateral mass fusion. Intraoperative Motor Evoked Potential (MEP) monitoring plays a crucial role in preventing iatrogenic neurological damage during these surgeries. However, obtaining reliable baseline MEP signals remains a challenge due to the suppressive effects of anesthetic agents on motor pathways.
This Phase 4, prospective, randomized controlled trial aims to compare the efficacy of two anesthetic regimens—Dexmedetomidine-Ketamine vs. Propofol-Fentanyl—in optimizing MEP signal acquisition during cervical lateral mass fusion. The study will evaluate MEP amplitude changes, hemodynamic stability, and intraoperative patient movement as primary and secondary outcomes. Target-Controlled Infusion (TCI) pumps will be used to precisely titrate anesthetic agents, maintaining optimal conditions for neurophysiological monitoring.
A total of 76 patients with cervical myelopathy scheduled for surgery will be recruited and randomized into two groups. Intraoperative MEP signals will be recorded at predefined time points, and postoperative neurological function will be assessed using Nurick’s grading at six months.
This study aims to establish an optimal anesthetic protocol for neuromonitoring, potentially improving surgical outcomes and patient safety in cervical spine surgeries. The findings may guide future anesthetic practices in spine surgery and neurophysiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18-65 years.
- •Diagnosed with cervical myelopathy (confirmed by MRI).
- •Scheduled for cervical lateral mass fusion with intraoperative MEP monitoring.
排除标准
- •Severe cardiac conditions (eg.severe coronary artery disease, heart failure).
- •Patients with Contraindications for MEP monitoring.
- •History of previous cervical spine surgery.
- •Inability to provide informed consent.
结局指标
主要结局
The primary outcome will focus on the MEP Amplitudes recorded from the Abductor Pollicis Brevis (APB), Tibialis Anterior (TA), Abductor Hallucis Longus (AHL), and Deltoid muscles
时间窗: At multiple key points during surgery like | At Baseline after induction- T0 | skin incision-T1 | After Decompression-T2 | After Screw Fixation-T3 | End of surgery-T4
次要结局
- MEP Phenotypes: Type 1-5 based on amplitude & latency(Patient Movement: Monitored to assess anesthesia effects on motor control.)
研究者
Dheeraj Masapu
Aster Whitefield Hospital
