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

NCT ID: NCT06088875

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2024-05-01

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group N (Nebulization group)

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.

Group Type: EXPERIMENTAL

Nebulization

Intervention Type: 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 S (Spray-as-you-go)

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.

Group Type: EXPERIMENTAL

Spray-as-you-go

Intervention Type: 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

Interventions

Nebulization

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

Intervention Type: DRUG

Spray-as-you-go

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Hassan El-Baradei

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud H El-Baradei, MBBCH

Role: CONTACT

mahmoud.elbaradei74@gmail.com

00201150242991

Facility Contacts

Mahmoud H El-Baradei, MBBCH

Role: primary

mahmoud.elbaradei74@gmail.com

00201150242991

Other Identifiers

36264MS159/4/23

Identifier Type: -

Identifier Source: org_study_id