Comparison Between Different Ways for Using Lidocaine During FB

Официальное название

Comparison Between Nebulized Lidocaine, Lidocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy: a Randomized Trial

Обзор

compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction .

Подробное описание

Flexible bronchoscopy (FB) is a commonly performed procedure in the diagnosis and treatment of several respiratory disease. Although FB is generally a short procedure, it is uncomfortable for the patient. At least the use of topical anesthesia during FB is essential, especially when performed without sedation. Effective topical anesthesia blunts airway reflexes such as gag, cough, and laryngospasm.

The reduction in cough not only improves patient comfort but also makes the procedure easier for the operator.

Among agents used for topical anesthesia, lidocaine is the most widely used drug because of its safety and favorable pharmacokinetic profile.

Lidocaine is available in various formulations (gel or solution) and can be delivered to the respiratory passages by using different modes (spray, nebulization, transtracheal injection, bronchoscope instillation, and others).

In this study, will compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for topical anesthesia in subjects undergoing diagnostic FB, for better outcome.

Вмешательства

• Процедура Nebulized lidocaine
  Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
• Процедура Lidocaine spray
  Subjects in group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.
• Процедура Combination of nebulized lidocaine and lidocaine spray
  Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.

Первичные конечные точки

• The severity of cough using cough severity index [Срок оценки: During and within 3 hours after procedure]
• pain during the procedure rated by the subjects on the Faces Pain Rating Scale. [Срок оценки: During and within 3 hours after procedure]
• time taken to cross the vocal cords. [Срок оценки: at the beginning of the procedure(time zero) till seconds after crossing the vocal cords]
• changes in heart rate [Срок оценки: During and within 3 hours after procedure]
• Changes in oxygen saturation [Срок оценки: During and within 3 hours after procedure]

Вторичные конечные точки (3)

• cumulative dose of lidocaine administered during the procedure. [Срок оценки: During the procedure]
• adverse reactions to lidocaine [Срок оценки: During and within 3 hours after procedure]
• overall satisfaction with the procedure using likert scale . [Срок оценки: During and within 3 hours after procedure]

Критерии участия

Критерии включения

• Patients above 18 years old will undergo FB are included in this study.

Критерии исключения

• known hypersensitivity to lidocaine.
• Pregnancy.
• hemodynamic instability.
• failure to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06563050 · Lidocaine use during FB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗