Comparison of effects of propofol and dexmedetomidine on motor evoked potentials inNeurosurgery a prospective randomised single blinded observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Amplitude of motor evoked potential (decrease of 50% or more from baseline)
研究概览
简要总结
Thisis a prospective randomised single blinded observational study to compare theeffects of propofol and dexmedetomidine on motor evoked potentials monitoringin neurosurgery that will be conducted in SCTIMST, Thiruvananthpuram. The primaryoutcome measures will be to compare the effects of the two drugs on amplitudeand latency of motor evoked potentials. The secondary outcome measures will beto compare the hemodynamic s, time to recovery and complications between thetwo anaesthetic regimens when used for monitoring motor evoked potentialsduring neurosurgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patient presenting for any spinal or intracranial surgery for a lesion involving motor cortex or pyramidal tract requiring intraoperative MEP monitoring.
排除标准
- •Patient refusal
- •Age less than 18 years and more than 60 years.
- •Autonomic instability
- •Long standing Diabetes mellitus (> 10 years)
- •Pregnant & nursing mothers
- •Motor power grade<3
- •Neuromuscular disease
- •Cardiopulmonary disease
- •skull defects at the region where electrodes need to be placed
- •intracranial apparatus (electrodes, vascular clips, and shunts), cardiac pacemakers, or other implanted pumps
- •renal and hepatic disease
- •history of chronic alcohol use
- •allergy to any of the anaesthetic agents used in the study
- •Preoperative heart rate < 50 bpm (beats per minute), presence of heart block
- •Antihypertensive medication with alpha methyl dopa, clonidine
- •Patient on beta blockers.
结局指标
主要结局
Amplitude of motor evoked potential (decrease of 50% or more from baseline)
时间窗: T1 - baseline value of MEP obtained when the T4/T1 reaches 0.9, and | before dividing the patients to two groups | T2 - 10 min after T1 when the dexmedetomidine loading dose infusion | would have just finished in D group. | T3- 10 minutes after T2 | T4 – 10 minutes after T3 | T5, T6 – recorded during the procedure | Tx – any other time if surgery requires it | Te – at the end of surgery
Latency of motor evoked potential (increase of 10% or more from baseline)
时间窗: T1 - baseline value of MEP obtained when the T4/T1 reaches 0.9, and | before dividing the patients to two groups | T2 - 10 min after T1 when the dexmedetomidine loading dose infusion | would have just finished in D group. | T3- 10 minutes after T2 | T4 – 10 minutes after T3 | T5, T6 – recorded during the procedure | Tx – any other time if surgery requires it | Te – at the end of surgery
次要结局
- heart rate, mean blood pressure trend (hemodynamic stability )(Amount of anaesthetic agents (amount of propofol and dexmedetomidine required))