Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.
- Conditions
- Superior Laryngeal Nerve BlockSedationDexmedetomidineAwake Fiberoptic IntubationHemimandibulectomyAnticipated Difficult Airway
- Interventions
- Drug: Superior laryngeal nerve block
- Registration Number
- NCT06651905
- Lead Sponsor
- Cairo University
- Brief Summary
This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.
- Detailed Description
Awake fiberoptic intubation (AFOI) has been recommended for adult patients with difficult airways. To make the process more tolerable, AFOI frequently requires sedation, anxiolysis, and hemodynamic stability without impairing ventilation and preserving spontaneous respiration. Intravenous dexmedetomidine, fentanyl, and midazolam are sedatives used during AFOI, commonly combined to decrease their side effects.
Dexmedetomidine is the drug of choice for many anesthesiologists for sedation in AFOI, as it produces sedation without respiratory depression in addition to its anxiolytic and analgesic properties. However, it can produce severe bradycardia and hypotension.
Airway nerve blocks are frequently used for AFOI, providing rapid and deep anesthesia. However, they carry a higher risk of complications, including nerve injury, intravascular injection, hematoma, or bleeding that may interfere with intubation. In addition, the presence of tumors or lymph nodes may not allow a successful block. To provide optimal airway anesthesia, it is advisable to block the superior laryngeal nerve (SLN) bilaterally and do the trans-tracheal injection for the recurrent laryngeal nerve.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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].
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine group Dexmedetomidine Patients were given 0.5 mcg/kg of dexmedetomidine over 10 minutes via a syringe pump, followed by a maintenance dose of 0.2-0.7 mcg/kg/hour until the end of intubation based on Hemodynamics. Superior laryngeal nerve block group Superior laryngeal nerve block Patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Egypt