Superior Laryngeal Nerve Block Versus Sedation with Intravenous Dexmedetomidine Infusion for Awake Fiberoptic Intubation of Hemimandibulectomy Patients with an Anticipated Difficult Airway: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The intubation score
研究概览
简要总结
This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range ≥ 18 or ≤
- •Both sexes.
- •American Society of Anesthesiologists (ASA) II-III.
- •Body mass index:18.5 to 30 kg/m
- •Hemimandibulectomy patients with an anticipated difficult airway [El-Ganzouri Risk Index (EGRI)>3].
排除标准
- •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.
研究组 & 干预措施
Dexmedetomidine group
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.
干预措施: Dexmedetomidine (Drug)
Superior laryngeal nerve block group
Patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.
干预措施: Superior laryngeal nerve block (Drug)
结局指标
主要结局
The intubation score
时间窗: 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.
次要结局
- 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)
- 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)
- Heart rate(From one minute before intubation to 10 minutes after intubation)
- Mean arterial pressure(From one minute before intubation till10 minutes after intubation)
- Ramsay sedation score(From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation)
- Patient satisfaction score(From the end of the operation to 24 hours postoperative)
- Incidence of complications(From the end of the operation to 24 hours postoperative)
研究者
Marwa Zayed
Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt
Cairo University