Comparing two methods of airway anesthesia for patients with jaw joint issues during intubation
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
This study is testing two ways to numb the airway during intubation for patients with jaw joint problems to see which method makes them more comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06088875 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two techniques for providing airway topical anesthesia—nebulization and a spray-as-you-go method—using a mixture of dexmedetomidine and lidocaine in patients with temporomandibular ankylosis. The focus is on patients undergoing awake flexible fiberoptic intubation, a procedure that requires patients to remain calm and cooperative while ensuring their airway is adequately anesthetized. The study will compare patient comfort and efficacy of anesthesia between the two methods to determine which is more effective for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 65 with temporomandibular joint ankylosis who are scheduled for elective surgery requiring general anesthesia.
Not a fit: Patients with a history of allergy to the study medications, significant comorbidities, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient comfort and safety during difficult intubation procedures.
How similar studies have performed: While the specific combination of techniques is novel, similar studies have shown that effective airway anesthesia is crucial for successful intubation in difficult airway scenarios.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud H El-Baradei, MBBCH
- Email: mahmoud.elbaradei74@gmail.com
- Phone: 00201150242991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.