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临床试验/CTRI/2025/10/096403
CTRI/2025/10/096403尚未招募2/3 期

Influence of dexmedetomidine nebulisation on isoflurane requirement in patients undergoing entropy guided general anaesthesia- a double blinded randomised control trial.

SNijalingappa medical college1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
to decrease the consumption of isoflurane consumption in patients receiving dexmedetomidine nebulisation and improve the patient recovery

研究概览

简要总结

Inhalational anaesthetic agents like Isoflurane are commonly used to maintain depth of anaesthesia but they are associated with adverse effects such as hemodynamic instability, respiratory depression and potential occupational hazards due to operating room pollution .Minimising the dose of these agents while maintaining adequate depth of anaesthesia is essential for optimizing patient safety

Dexmedetomidine is a potent centrally acting highly sedative alpha 2 receptor agonist with sympatholytic, amnestic, analgesic, anxiolytic properties .

Nebulised dexmedetomidine offers a non-invasive, patient friendly alternative for premedication, which may help attenuate the intraoperative stress response and reduce the requirement of inhaled agent

Entropy monitoring, derived from electroencephalographic signals, enables realtime titration of anaesthetic agents, ensuring precise control over anaesthetic depth. Integrating entropy guidance with dexmedetomidine nebulization may potentially lower isoflurane consumption, reduce sympathetic stimulation and minimize perioperative complications thereby improving the recovery profile of patients.Despite promising pharmacological profiles, there is limited literature on the combined use of nebulized dexmedetomidine and entropy guided anaesthesia.

This gap underscores the need for further investigation to validate its efficacy in reducing inhalational agent requirements, improving hemodynamic stability, and minimizing intraoperative hazards.Thus, this study aims to evaluate the efficacy of nebulized dexmedetomidine in reducing the requirement of inhalational anaesthetics using entropy-guided monitoring and recovery in terms of time required for eye opening and extubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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 scheduled for elective surgeries requiring general anaesthesia lasting for less than 2 hours.
  • patients belonging to ASA 1 & 2.

排除标准

  • patients under going emergency surgeries .
  • Obese individuals (BMI more than 30).
  • patients with known allergy to dexmedetomidine.
  • patients belonging to ASA 3 &
  • Patients with cardiovascular and respiratory disorders.

结局指标

主要结局

to decrease the consumption of isoflurane consumption in patients receiving dexmedetomidine nebulisation and improve the patient recovery

时间窗: 72hours

次要结局

  • to decrease the complications & to maintain the hemodynamic status(72 hours)

研究者

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

Dr Sangamesh Nainegali

S.Nijalingappa medical college and HSK hospital,Bagalkot.

研究点 (1)

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