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临床试验/CTRI/2024/09/073964
CTRI/2024/09/073964招募中Unknown

Effect of Etomidate and Ketamine on Optic Nerve Sheath Diameter in severe Traumatic Brain Injury patients undergoing Rapid Sequence Intubation in Emergency Department: ARandomized Controlled Trial.

NA1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年9月26日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
NA
入组人数
62
试验地点
1
主要终点
Average change in optic nerve sheath diameter before and after

研究概览

简要总结

Traumatic Brain Injury(TBI) has been one of the leading causes of morbidity and mortality all around the. world. During airway management in TBI, there are chances of an increase in Intracranial pressure (ICP) due to intubation, hypoxia, and hemodynamic instability.ICP is highly dynamic and changes instantly during intubation. In the literature, there is no specific drug that provides ideal incubating conditions for acute TBI patients. To provide sedation before the procedure Etomidate has long been the drug of choice. However, Etomidate

causes adrenal suppression and increases the risk of morbidity and mortality. Ketamine has emerged as a drug of choice in many such patients recently since it does not cause hypotension, has analgesic properties and its cerebral protection effect is being studied. Ultrasonography of optic nerve sheath diameter (ONSD) has been correlated with an increase in ICP as an optic nerve sheath. However, there are no studies in the literature comparing the efficacy of these drugs on ICP changes in acute TBI patients. This study will compare both these drugs and provide a better option of induction agent for rapid sequence intubation in traumatic brain injury patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 62.00 Year(s)(—)
性别
All

入选标准

  • With traumatic brain injury presenting to ED and requiring a rapid sequence intubation.
  • Patient relatives are willing to participate in the study.

排除标准

  • Hemodynamic instability( hyper or hypotension) during RSI Predicted difficult intubation by LEMON scoring Patients with open skull injuries Patients with eyeball globe injuries, orbital mass or tumors.
  • Patients with H/O any neurosurgical procedures.
  • Nontraumatic brain injuries pregnancy Anti-edema therapy like Mannitol infusion started before arrival at ED Contraindication or Hypersensitivity to any used drug.
  • • Other organ injury causing likelihood of low GCS.

结局指标

主要结局

Average change in optic nerve sheath diameter before and after

时间窗: Parameters Wii be taken 3 minutes before induction ,5 and 10 minutes following induction.The patient will be followed up for next 24 hour.

administration of induction drugs

时间窗: Parameters Wii be taken 3 minutes before induction ,5 and 10 minutes following induction.The patient will be followed up for next 24 hour.

次要结局

  • 1. Hemodynamic changes(2. Successful first pass intubation)

研究者

发起方
NA
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Dr P Santhosh

AIIMS,BHUBANESWAR

研究点 (1)

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