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Clinical Trials/CTRI/2021/10/037256
CTRI/2021/10/037256Not yet recruitingPhase 2/3

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 site in 1 country80 target enrollmentStarted: October 17, 2021Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
80
Locations
1
Primary Endpoint
1.sedation/alertness(OAA SCORE)

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

1.sedation/alertness(OAA SCORE)

Time Frame: 0 to 5 min

2.vocal cord movement(%)

Time Frame: 0 to 5 min

3.limb movement

Time Frame: 0 to 5 min

4.fibreoptic intubation score

Time Frame: 0 to 5 min

5.coughing

Time Frame: 0 to 5 min

Secondary Outcomes

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

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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