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临床试验/NCT04716439
NCT04716439Unknown不适用

Effect of Total Intravenous Anesthesia (TIVA) With Magnesium Sulfate on Intra-Operative Neuromonitoring (IONM) in Patients Undergoing Spine Surgery

King Khalid University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月最近更新:
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适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
IONM Reading
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Anesthesia for neurosurgery requires balancing deep and effective anesthesia as well as postoperative analgesia versus the risks of delayed recovery and postoperative respiratory depression. This randomized placebo-controlled, double-blind study was designed to evaluate the effect of magnesium sulfate on the total anesthetic and analgesic consumption using the clinical parameters in addition to the effect on IONM reading.

详细描述

Objectives:

  1. Decrease anesthetic consumption
  2. Decrease use of muscle relaxants
  3. Decrease analgesic consumption
  4. Excellent recovery

Patients & Methods:

  • 2 groups (total 50) Randomized Controlled Double Blind (RCDB) Study
  • Propofol + remifentanil + saline (Control = C group)
  • Propofol + remifentanil + Mgso4 (Magnesium = M group)
  • Adult Spine decompression and fixation After getting the Institutional Review Board (IRB) approval, This randomized controlled double blind study includes 2 groups of patients (each group 25) will be enrolled in the study. All patients undergo spine decompression and fixation surgery

Induction:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 60 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Adult Patients Undergoing Spine Surgery

排除标准

  • •Renal Impairment
  • •Liver Cell failure
  • •Heart Block

结局指标

主要结局

IONM Reading

时间窗: 1- baseline 2-during surgery 3-immediately after surgery

Reading the effect on the intraoperative neuromonitoring either motor or sensory evoked potential

次要结局

  • Blood Pressure(1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours)
  • Morphine Consumption(Over 24 hours postoperative)
  • Heart Rate(1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours)
  • Pain Score(Over 24 hours postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Essam M. Manaa (MD)

Assistant Professor & Consultant

King Khalid University Hospital

研究点 (1)

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