Anticipated Difficult Airway, Awake Fiberoptic Intubation, Dexmedetomidine, Hemimandibulectomy, Sedation, Superior Laryngeal Nerve Block
Conditions
Brief summary
This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.
Interventions
DRUGDexmedetomidine
The patients were given 0.5 mcg /kg dexmedetomidine over 10 min via syringe pump, followed by 0.2-0.7 mcg/kg/hour until the end of intubation according to hemodynamics.
The patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age range ≥ 18 or ≤60. * Both sexes. * American Society of Anesthesiologists (ASA) II-III. * Body mass index:18.5 to 30 kg/m2. * Hemimandibulectomy patients with an anticipated difficult airway \[El-Ganzouri Risk Index (EGRI)\>3\].
Exclusion criteria
* Patient's refusal. * Known allergy to drugs used in the study. * Neurological disorders. * Advanced liver or kidney disease. * Patient with psychiatric disorders. * Patient who needs postoperative ICU. * Airway distortion and cervical spine movement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The intubation score | time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords.Time range of 10 minutes | The intubation conditions score is assessed based on the following criteria: (i) Vocal movement: 1 = open, 2 = moving, 3 = closing, 4 = closed. (ii) Coughing: 1 = none, 2 = slight, 3 = moderate, 4 = severe. (iii) Limb movement: 1 = none, 2 = slight, 3 = moderate, 4 = severe. Where The Intubation conditions score is : Excellent = 1 when all qualities are excellent. Good = 2 when all qualities are either excellent or good. Poor = 3 when the presence of a single poor quality is noted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The degree of comfort | time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords. Time range of 10 minutes | The comfort score was evaluated using a five-point fiberoptic intubation comfort scale: 1 = no reaction, 2 = slight grimace, 3 = heavy grimace, 4 = verbal objection, and 5 = defensive movement of head and hands. |
| Degree of airway obstruction | time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords Time range of 10 minutes | The degree of airway obstruction (1 - absent, 2 - requiring neck extension, 3 - requiring jaw thrust) was noted |
| Heart rate | From one minute before intubation to 10 minutes after intubation | Heart rate is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation. |
| Mean arterial pressure | From one minute before intubation till10 minutes after intubation | Mean arterial blood pressure is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation. |
| Ramsay sedation score | From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation | Ramsay sedation score was recorded as follows: 1: Awake, agitated or restless or both; 2: Awake, cooperative, oriented, and tranquil; 3: Awake but responds to commands only; 4: Asleep, with a brisk response to a light glabellar tap or loud auditory stimulus. |
| Patient satisfaction score | From the end of the operation to 24 hours postoperative | The patient satisfaction score (1-excellent, 2-good, 3-reasonable, 4-poor) was documented. |
| Incidence of complications | From the end of the operation to 24 hours postoperative | Adverse events such as bradycardia, hypotension, nausea, vomiting, pruritus, respiratory depression, O2 desaturation, or any other complications were recorded. |
Countries
Egypt
Outcome results
None listed