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临床试验/CTRI/2024/09/073165
CTRI/2024/09/073165尚未招募4 期

Comparison between lignocaine nebulization and airway nerve block for awake fiberoptic bronchoscopy-guided nasotracheal intubation: a single-blind randomized prospective study

Dr Ram Nandan Prasad Professor Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the intubation time of the two techniques

研究概览

简要总结

Airway management is an important part of anesthesia, providing ventilation, oxygenation, preventing aspiration, and working as a mode of distribution anesthetic gasses. This is an important skill and area of focus for the anesthetist because sometimes it is very difficult to maintain or manage the airway and this can be life-threatening. The awake fiberoptic endoscope intubation (AFOI) technique is the gold standard in the treatment of patients with suspected airway difficulty, especially before induction of anesthesia.1 It is important to prepare patients before AFOI. The thought of being awake and having a nasotracheal procedure can be very stressful for a patient who is not mentally prepared, so adequate time and effort should be spent preparing patients and by using different pharmacological modalities. The anesthesiologist should guide and prepare the patients by explaining procedure in details in their mother tongue. 2 Preparation also includes blocking airway reflexes, providing adequate sedation, preventing anxiety and maintaining airway patency and adequate ventilation. Awake fiberoptic intubation includes facial fractures, cervical spine instability,some partial obstructive laryngeal lesions (e.g., papilloma), craniofacial abnormalities, and temporomandibular joint ankylosis. 3,4 It can also be used to maintain the patency of airway in several conditions like in cervical spine unstability where manipulation of patient’s neck is likely to be difficult. In cases where cervical spine immobile or instable, applying of rigid cervical collar can reduce cervical spine movements and it hampers tracheal intubation by using standard laryngoscope.5 This procedure reduces the risk of nerve damage before the onset of surgical procedure. Before intubation under awake FOB guidance, it is essential to sufficiently anesthetize upper airway and suppress the swallow, gag and coughing reflexes prior to guided intubation and thus ensure patient comfort.6 This can be attained by different ways, which can be divided into two groups: (a) Local application of local anesthetic agent, or (b) blockade of neural supply to oropharynx and larynx.Local applications of LA in sprays, mouthwashes, lozenges, or nebulized forms cause less damage to the airway compared to nerve blocks. Also, the risk of inadvertent injection into blood vessels is avoided. In contrast, nerve block techniques usually require a small amount of local anaesthetic, which may reduce risk of systemic toxicity. 7Airway nerve blocks are in the form of glossopharyngeal, superior laryngeal (SLN) and trans tracheal block to abolish gag reflex, closure of the glottis and reflex coughing. 8 To complete anesthesia, it is recommended to block the glossopharyngeal nerve (GPN) and superior laryngeal nerve (SLN) both sides and transtracheal injection for recurrent laryngeal nerve. Glossopharyngeal nerve can be blocked intraorally and extraorally but it is associated with complications and it is recommended not to use the later approach due to close proximity of the vagus nerve. 9 Airway nerve blocks are mostly used for awake fiberoptic intubation because they provide rapid and deep anesthesia. Nebulization of local anesthetics is also effective technique, which provide complete anaesthesia without the need for multiple painful injections. Therefore, we will compare nerve block, which is considered the standard procedure for achieving rapid and effective airway anesthesia, with lignocaine nebulization, which constitutes a simple, painless, and comfortable alternative method for anesthetizing the airway. When carried out under minimal sedation these techniques help to allay anxiety so the patient is more cooperative during the procedure. In our study, before awake fiberoptic bronchoscopy-guided intubation, we used dexmedetomidine infusion for procedural sedation, which results in a stable hemodynamic profile and prevents desaturation by preserving the respiratory function of the patient. This randomized study will be conducted to compare the efficacy of jet nebulization of lignocaine and airway nerve block for providing airway anesthesia before awake fiberoptic bronchoscopyguided intubation.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA I and ASA II and BMI between 20-35.

排除标准

  • Patients who will not provide consent.
  • Contradictions or allergy to any study drug.
  • Patient having asthma, epilepsy, hemodynamically instability, or a deranged coagulation profile.
  • Pregnant and Breast- feeding women.

结局指标

主要结局

To compare the intubation time of the two techniques

时间窗: Intaoperative period of the two techniques

次要结局

  • To assess the quality of airway anesthesia, the degree of patient comfort, and post-operative(patient satisfaction.)

研究者

发起方
Dr Ram Nandan Prasad Professor Department of Anaesthesia
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Aryan Chahal

MM Institute of Medical Sciences and Research Centre, Ambala

研究点 (1)

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