Dexmedetomidine Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 ß-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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | El-Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse events. | Adverse events (bradycardia, hypotension, laryngeal spasm, lidocaine toxicity). Hypotension (MAP < 20% of baseline readings ). Bradycardia (HR < 50 beats/min | From intervention for 4hours | |
Secondary | Time till successful intubation. | Time needed till successful intubation. Direct visualization of the endotracheal tube passing through the vocal cords into the trachea. | Immediately after intubation | |
Secondary | Post-operative sore throat. | Sore throat will be evaluated at PACU 1, 12 and 24h after extubation, during the post-operative period.
Grading of Post-operative sore throat (POST) will be done using a four-point scale (0-3) : 0 for no sore throat; 1 for mild sore throat (complains of sore throat only when asked); 2 for moderate sore throat (complains of sore throat even without asking); and 3 for severe sore throat (with change of voice or hoarseness, also may be associated with throat pain). |
24 hours after extubation |
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