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临床试验/CTRI/2025/03/083229
CTRI/2025/03/083229尚未招募4 期

A comparison of intravenous dexmedetomidine vs. nebulized dexmedetomidine for awake fiberoptic bronchoscope guided intubation in head and neck surgery: A prospective, double blind, randomized trial.

Rajendra Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年4月4日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
128
试验地点
1
主要终点
To obtain 5-point intubation comfort score for assessing patient tolerance.

研究概览

简要总结

Awake fiberoptic intubation is gold standard for anticipated difficult airway. Nebulized dexmedetomidine is speculated to have lesser adverse effects, easy to administer and better tolerated by patients.

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 70.00 Year(s)(—)
性别
All

入选标准

  • a)The patient giving written and informed consent for study.
  • b)Patient posted for elective head and neck surgeries requiring elective nasal intubation.
  • c)All those patients having anticipated difficult airway.
  • d)Patients with ASA grade I and II.
  • e)Male and female patients aged between 18-70 years.

排除标准

  • a) Patients having a clinical diagnosis of any systemic disease.
  • b) Patients with severe renal or hepatic impairment.
  • c) Patient having any intra oral mass.
  • d) Patients with history of alcohol or drug addiction.
  • e) Patient having any predisposition to intra oral bleeding.
  • f) Patients having allergy to the study drugs.
  • g) Patients with cognitive impairment or communication problem.
  • h) Patient requiring conversion from use of sedative to general anesthesia.

结局指标

主要结局

To obtain 5-point intubation comfort score for assessing patient tolerance.

时间窗: At time points from point of insertion of bronchoscope till intubation.

次要结局

  • a) To compare hemodynamic variables and associated changes from intubation.(b) To compare time required for intubation from the point of insertion of fibreoptic bronchoscope to successful placement of ET tube.)

研究者

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

DR KUMAR ANAND

RAJENDRA INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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