跳至主要内容
临床试验/CTRI/2025/02/080449
CTRI/2025/02/080449尚未招募4 期

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

Aster Intramural Research Funding1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年2月24日最近更新:

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

发起方
Aster Intramural Research Funding
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dheeraj Masapu

Aster Whitefield Hospital

研究点 (1)

Loading locations...

相似试验