Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis

Last updated: October 18, 2023
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Treatment

Spray-as-you-go

Nebulization

Clinical Study ID

NCT06088875
36264MS159/4/23
  • Ages 21-65
  • All Genders

Study Summary

The aim of this study is to compare the efficacy of airway topical anesthesia with nebulization to the spray-as-you-go technique using dexmedetomidine and lidocaine mixture to achieve upper airway anesthesia in TMJ ankylosis patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 21to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I or II and scheduled forelective surgery requiring general anesthesia , and known to have Temporomandibularjoint ankylosis and expected to be difficult intubation patient due to restriction ofjaw mobility and limited mouth opening less than 2 fingers.

Exclusion

Exclusion Criteria:

  • History of allergy to dexmedetomidine or lidocaine.
  • History of drug abuse.
  • Concomitant use of medications which may exaggerate the heart rate (HR) response of -dexmedetomidine (e.g. digoxin or β-adrenergic antagonists), HR <50 beats/min,systolic blood pressure (SBP) <90 mmHg.
  • Pregnancy.
  • Morbid obesity( BMI more than 35).
  • Patients on anticoagulants, nasal trauma, deformity or polyp, CSF rhinorrhea, fracturebase skull.
  • Cardiac and/or respiratory disease, reactive airway disease, hepatic or renaldisorders.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Spray-as-you-go
Phase:
Study Start date:
October 18, 2023
Estimated Completion Date:
May 01, 2024

Study Description

Awake fiber-optic intubation (AFOI) has become the accepted gold standard technique for management of recognized difficult airway as the larynx remains in a posterior position and the patient is able to protect the airway from soiling and can maintain the airway patency as well as spontaneous breathing efforts. Awake intubation requires that the patient remains calm and cooperative and is provided with sufficient anxiolysis, analgesia, and topical anesthesia without compromising the airway.

Gag reflex, cough, and laryngospasm can be upsetting during the process. Awake patients never permit airway instrumentation without airway anesthesia. Therefore, effective airway anesthesia is required for airway instrumentation and patient comfort.

For awake intubation, topical airway anesthesia can be provided either by using fiberoptic bronchoscope (FOB) to apply local anaesethic to the airway by a "spray-as-you-go" technique or nebulizing the patient for about 10-15 min.

Connect with a study center

  • Tanta University

    Tanta, El-Gharbia 31527
    Egypt

    Active - Recruiting

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