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Clinical Trials/CTRI/2024/06/068262
CTRI/2024/06/068262
Not yet recruiting
Phase 2

Comparison of effectiveness of nebulization with lignocaine alone or with dexmedetomidine in patients undergoing awake nasotracheal intubation under fiber optic guidance.

Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK1 site in 1 country50 target enrollmentStarted: June 15, 2024Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK
Enrollment
50
Locations
1
Primary Endpoint
Time required for intubation

Overview

Brief Summary

Airway management has significantly improved, but difficult airways remain a major challenge for anesthetists, causing 25% of anesthesia-related deaths. When a difficult airway is expected, securing the airway while the patient is awake is the safest approach. Fiberoptic bronchoscopy, introduced in 1967, is the gold standard for managing difficult airways, with a success rate of 88%-100%. It allows direct guidance and can be performed while the patient is awake, maintaining oxygenation. Effective airway anesthesia is essential and can be achieved using local anesthetics through various techniques, such as sprays, gargles, and nebulization, or by blocking specific nerves. Nebulization is simple, non-invasive, and effective for awake fiberoptic intubations, though it might need supplementation with nerve blocks or the spray-as-you-go (SAYGO) technique. Dexmedetomidine, an α2 adrenoreceptor agonist, provides sedation without significant respiratory depression and reduces salivary secretions, making it suitable for awake fiberoptic intubation. It has anxiolytic, hypnotic, analgesic, amnesic, and antisialogogue properties. Nebulized dexmedetomidine, combined with lidocaine, has been effective for awake videoendoscopic intubations, reducing coughing and recovery time. This study aims to evaluate the effectiveness of adding dexmedetomidine to lignocaine nebulization for awake fiberoptic nasotracheal intubation in patients with predicted difficult airways, as current literature lacks sufficient evidence-based recommendations.

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

  • A total of 50 patients, age group 18-60 years, either gender, belonging to ASA physical status I, II having anticipated difficult airways schedule to undergo elective surgery under general anaesthesia and requiring endotracheal intubation will be enrolled.

Exclusion Criteria

  • Refusal to participation, non-cooperative patient, Psychiatric conditions, Allergic to study drugs, Bradycardia and hypotension, Nasal pathology, Coagulation abnormalities, Intracranial hypertension & glaucoma, Pregnancy and lactation.

Outcomes

Primary Outcomes

Time required for intubation

Time Frame: At the baseline.

Secondary Outcomes

  • Success rate,(Number of attempts taken,)

Investigators

Sponsor
Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Renu Bala

Pt. B D Sharma, PGIMS, Rohtak

Study Sites (1)

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