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Clinical Trials/CTRI/2025/12/098795
CTRI/2025/12/098795Not yet recruitingUnknown

Comparison Of Nebulized Dexmedetomidine Plus Lidocaine Combination Versus Nebulized Dexmedetomidine Alone For Awake Fiberoptic Nasotracheal Intubation A Prospective Randomized Controlled Study

Pradipta Laha1 site in 1 country88 target enrollmentStarted: December 25, 2025Last updated:

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Sponsor
Enrollment
88
Locations
1

Study Overview

Brief Summary

This Prospective Randomized controlled study is the comparison of nebulized dexmedetomidine plus lidocaine versus dexmedetomidine alone in awake nasotracheal fiberoptic intubation. The place of study is Command Hospital Eastern Command  a tertiary care teaching hospital in Kolkata . The total duration of the study is 16 months.  Total Number of participants in the study is 88. The inclusion criteria of the study are age between 18 to 65 years with ASA physical status I to II who are scheduled for elective surgery under general anaesthesia. The participants will be divided into two groups 44 in each. Group DL will receive nebulized dexmedetomidine combined with lidocaine and group DN will receive nebulized dexmedetomidine with normal saline which will be administered 20 minutes prior to awake fiberoptic intubation. Premedication will be given in both the groups. The primary objective is to compare the time required for awake fiberoptic nasotracheal intubation between the two groups. The secondary objectives of this study is to assess the ease and quality of awake fiberoptic nasotracheal intubation. This study aims to evaluate whether the addition of nebulized lidocaine improves the outcome compared to nebulized dexmedetomidine alone during awake fiberoptic nasotracheal intubation. The study is a double blinded study where the participants and professional performing the procedure will be blinded. Randomization will be done by sealed opaque envelopes.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA Physical Status I-II Schedule For Elective Surgery Under General Anaesthesia With AFOI Informed Written Consent.

Exclusion Criteria

  • Patient Unwilling To Participate Nasal Obstruction Polyps Bleeding Disorders Allergy To Lidocaine Or Dexmedetomidine Pregnant Women.

Investigators

Sponsor
Pradipta Laha
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Pradipta Laha

Command Hospital Eastern Command

Study Sites (1)

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