Clinical trial

Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis: A Randomized Double-Blind Trial

Name

36264MS159/4/23

Description

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.

Trial arms

Trial start

2023-10-18

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Recruiting

Treatment

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

Arms:

Group N (Nebulization group)

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

Arms:

Group S (Spray-as-you-go)

Size

Primary endpoint

Ease of successful intubation

Immediately after intubation

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-10-19

1 organization

2 products

5 indications

Organization

Tanta University

Product

Nebulization

Indication

Inhalation Therapy

Indication