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临床试验/CTRI/2024/05/067977
CTRI/2024/05/067977尚未招募4 期

Comparing the effect of lignocaine infusion on motor evoke potential (MEP) with dexmedetomidine infusion in intraoperative neuromonitoring cases

Amrita Institute of medical sciences1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年7月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
164
试验地点
1
主要终点
Compare the Lignocaine infusion and Dexmedetomidine infusion on Motor evoked potential during intraoperative neuromonitoringÂ

研究概览

简要总结

This is a randomized observational study conducted in 168 patients undergoing surgery under general anesthesia. There will be 2 groups of patients. One group of patients will be those who are receiving dexmediotmidine as an adjuvant to general anesthesia.  Other group consists of patients receiving lignocaine as an adjuvant.Both group receive general anesthesia as per standard protocol. The patients motor evoke potential will be noted after 30 minutes, after positioning the patient prone and 30 minutes and 1 hour.Hemodynamic variables will be noted along the same time. At the endo surgery intraoperative fenatnyl consumption is noted. The time interval between the  ending of infusion and the response of the patient  to call by eye opening will bw also recorded .The date from both will be be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients scheduled for spine surgery with normal motor power Grade of
  • Patients with ASA grade 1,2,3.

排除标准

  • Any patients with an allergy to lignocaine.Any patient for emergency surgery.

结局指标

主要结局

Compare the Lignocaine infusion and Dexmedetomidine infusion on Motor evoked potential during intraoperative neuromonitoringÂ

时间窗: The measurement of motor evoke potential  after 30 minutes initial bolus of infusion. Then subsequent measurement immediately after positioning prone and 30 minutes and one hour of surgery, The time interval between the stoppage of the infusion and patient response to call also will ne taken

次要结局

  • Dose of intraoperative fentanyl,hemodynamic variables,awakening time from end of infusion.(dose of fentanyl and isoflurane at end of surgery haemodynamic variables 3,5 minutes after bolus and after positioning then every 30 minutes.Time taken to awake after infusion)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Eldo Issac

Amrita Institute of Medical Sciences

研究点 (1)

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