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临床试验/CTRI/2025/03/082745
CTRI/2025/03/082745尚未招募4 期

Comparison between Nebulized and Intravenous Dexmedetomidine as an additive to Nebulized Lignocaine for Awake Fiberoptic Intubation

Eras Lucknow Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To assess the total duration required for awake fiberoptic intubation.

研究概览

简要总结

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

  • Patients belonging to American Society of Anaesthesiologists physical status I or II.
  • Patients scheduled to undergo elective surgery under general anaesthesia.
  • Patients with predicted difficult airway (defined as mouth opening less than 3 cm or thyromental distance less than 6.5 cm or sternomental distance less than 12.5 cm or modified Mallampati class III/IV, or limited neck movements).

排除标准

  • Patients with known or suspected allergy to Dexmedetomidine or Lignocaine.
  • Patients with thrombocytopenia or bleeding diathesis.
  • Patients with psychiatric disorder or uncooperative patients.
  • HR less than 50 bpm.
  • Second or third degree heart block.
  • Pregnancy and lactation.

结局指标

主要结局

To assess the total duration required for awake fiberoptic intubation.

时间窗: Less than 15 mins

次要结局

  • 1 To assess the patient comfort and tolerance during intubation using patient tolerance score (PTS).(2 To assess the degree of sedation using Ramsay sedation score (RSS).)

研究者

发起方
Eras Lucknow Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shirin Parveen

Eras Lucknow Medical College and Hospital

研究点 (1)

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