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临床试验/CTRI/2021/10/037256
CTRI/2021/10/037256尚未招募2/3 期

A Comparative Evaluation Of Efficacy Of Nebulisation With Dexmedetomidine And Nebulisation With 4% Lignocaine Plus Dexmedetomidine For Awake Fibreoptic Intubation In Difficult Airway Scenario: A Randomized Control Trial

Indira Gandhi institute of medical sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年10月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
1.sedation/alertness(OAA SCORE)

研究概览

简要总结

A COMPARATIVE EVALUATION OF EFFICACY OF NEBULIZATION WITH DEXMEDETOMIDINE AND NEBULIZATION WITH 4% LIGNOCAINE PLUS DEXMEDETOMIDINE FOR AWAKE FIBEROPTIC INTUBATION IN DIFFICULT AIRWAY SCENARIO

Different topical and regional techniques have been developed to subdue reflexes and facilitate awake fiberoptic intubation .It is essential to sufficiently anesthetize the upper airway and suppress the gag, swallow ,and cough reflexes prior to awake fiberoptic intubation and thus ensure patient comfort

PRIMARY OBJECTIVES:

A comparative double blinded randomised study will be performed-

  1. To evaluate the effect of preoperative nebulisation with dexmedetomidine and preoperative nebulisation with dexmedetomidine plus lignocaine for awake fiberoptic intubation on-

a) sedation/alertness

b) vocal cord /limb movement

c) coughing

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • patient consent, ASA grade 1 and 2, patient with anticipated difficult intubation(LEMON >2), BMI >30 kg/m2.

排除标准

  • patient refusal, airway hypersensitivity, allergy to drugs used (lignocaine/dexmedetomidine),epileptic patients,patients with poor cardiopulmonary reserve, bleeding tendency, obesity, other co-morbid conditions.

结局指标

主要结局

1.sedation/alertness(OAA SCORE)

时间窗: 0 to 5 min

2.vocal cord movement(%)

时间窗: 0 to 5 min

3.limb movement

时间窗: 0 to 5 min

4.fibreoptic intubation score

时间窗: 0 to 5 min

5.coughing

时间窗: 0 to 5 min

次要结局

  • 1) To compare the hemodynamic changes of two groups(2) Dose sparing effect of propofol)

研究者

申办方类型
Government medical college

研究点 (1)

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