跳至主要内容
临床试验/CTRI/2024/06/068262
CTRI/2024/06/068262
尚未招募
2 期

Comparison of effectiveness of nebulization with lignocaine alone or with dexmedetomidine in patients undergoing awake nasotracheal intubation under fiber optic guidance.

Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月15日最近更新:

概览

阶段
2 期
状态
尚未招募
发起方
Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK
入组人数
50
试验地点
1
主要终点
Time required for intubation

概览

简要总结

Airway management has significantly improved, but difficult airways remain a major challenge for anesthetists, causing 25% of anesthesia-related deaths. When a difficult airway is expected, securing the airway while the patient is awake is the safest approach. Fiberoptic bronchoscopy, introduced in 1967, is the gold standard for managing difficult airways, with a success rate of 88%-100%. It allows direct guidance and can be performed while the patient is awake, maintaining oxygenation. Effective airway anesthesia is essential and can be achieved using local anesthetics through various techniques, such as sprays, gargles, and nebulization, or by blocking specific nerves. Nebulization is simple, non-invasive, and effective for awake fiberoptic intubations, though it might need supplementation with nerve blocks or the spray-as-you-go (SAYGO) technique. Dexmedetomidine, an α2 adrenoreceptor agonist, provides sedation without significant respiratory depression and reduces salivary secretions, making it suitable for awake fiberoptic intubation. It has anxiolytic, hypnotic, analgesic, amnesic, and antisialogogue properties. Nebulized dexmedetomidine, combined with lidocaine, has been effective for awake videoendoscopic intubations, reducing coughing and recovery time. This study aims to evaluate the effectiveness of adding dexmedetomidine to lignocaine nebulization for awake fiberoptic nasotracheal intubation in patients with predicted difficult airways, as current literature lacks sufficient evidence-based recommendations.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • A total of 50 patients, age group 18-60 years, either gender, belonging to ASA physical status I, II having anticipated difficult airways schedule to undergo elective surgery under general anaesthesia and requiring endotracheal intubation will be enrolled.

排除标准

  • Refusal to participation, non-cooperative patient, Psychiatric conditions, Allergic to study drugs, Bradycardia and hypotension, Nasal pathology, Coagulation abnormalities, Intracranial hypertension & glaucoma, Pregnancy and lactation.

结局指标

主要结局

Time required for intubation

时间窗: At the baseline.

次要结局

  • Success rate,(Number of attempts taken,)

研究者

发起方
Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Renu Bala

Pt. B D Sharma, PGIMS, Rohtak

研究点 (1)

Loading locations...

相似试验