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Clinical Trials/CTRI/2025/11/097139
CTRI/2025/11/097139Not yet recruitingPhase 3 4

A clinical study comparing effectiveness of intranasal versus intravenous dexmedetomidine for attenuation of hemodynamic responses of laryngoscopy and endotracheal intubation n patients undergoing general anaesthesia.

Chatrapati Shivaji Subharti Hospital1 site in 1 country80 target enrollmentStarted: December 1, 2025Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Heart Rate

Study Overview

Brief Summary

There are many literature regarding  intravenous dexmedetomidine in attenuating the response to laryngoscopy and intubation but there is a lack of enough literature regarding intranasal use of dexmedetomidine for attenuation of response to laryngoscopy and intubation. Intranasal route is helpful preferred as it avoids needle anxiety and semi invasive.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

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

Inclusion Criteria

  • ASA (American Society of Anesthesiologists) grade 1 and 2.

Exclusion Criteria

  • Patient refused to participate Patient with known allergy and hypersensitivity to study drug.

Outcomes

Primary Outcomes

Heart Rate

Time Frame: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

Systolic Blood Pressure

Time Frame: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

Diastolic Blood Pressure

Time Frame: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

MAP (Mean arterial pressure)

Time Frame: Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute.

Secondary Outcomes

  • Post-operative sedation(Ramsay sedation score)(Baseline, At Intubation, 1 Hour, 2 Hour, 4 Hour, 6 Hour.)

Investigators

Sponsor
Chatrapati Shivaji Subharti Hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

PAVANKUMAR S HANDRAL

Subharti Medical College

Study Sites (1)

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