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

NCT06088875 | Unknown

• 1 other identifier: 36264MS159/4/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nebulization; Spray-as-You-Go; Dexmedetomidine; Lidocaine; Temporomandibular Ankylosis

Outcome Measures

Primary Outcomes (1)

• Ease of successful intubation

  Ease of successful intubation will be measured by the composite score which is a composite of five parameters with a score of 1-5 for each parameter, 1 indicating best possible condition and higher scores indicating worsening of the conditions for intubation . The maximum score was 25. A score of \<10 was considered optimal, 10-15

  Immediately after intubation

Secondary Outcomes (3)

• Adverse events.

  From intervention for 4hours

• Time till successful intubation.

  Immediately after intubation

• Post-operative sore throat.

  24 hours after extubation

Study Arms (2)

Group N (Nebulization group)

EXPERIMENTAL

Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg nebulization + saline 10 ml via spray-as-you-go technique.

Drug: Nebulization

Group S (Spray-as-you-go)

EXPERIMENTAL

Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization.

Drug: Spray-as-you-go

Interventions

Nebulization DRUG

Patients will be nebulized with mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg by using wall nebulizer for 15 min before awake fiberoptic intubation. Patients in group S will receive saline 10 ml nebulization

Group N (Nebulization group)

Spray-as-you-go DRUG

Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization. Patients in group N will receive saline via spray-as-you-go technique

Group S (Spray-as-you-go)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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, fracture base skull.
• Cardiac and/or respiratory disease, reactive airway disease, hepatic or renal disorders.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Temporomandibular ankylosis

Central Study Contacts

Mahmoud H El-Baradei, MBBCH

CONTACT

00201150242991; mahmoud.elbaradei74@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 18, 2023
• Study Start: October 18, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)