Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation

Официальное название

Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Functional Endoscopic Sinus Surgery and Nasal Reconstruction (Prospective, Randomized, Controlled Clinical Study).

Обзор

compare the efficacy of intratracheal dexmedetomidine versus intratracheal lidocaine in achieving smooth tracheal extubation in patients undergoing Functional Endoscopic Sinus surgery and reconstructive nasal surgeries under general anesthesia.

Подробное описание

undergoing Functional Endoscopic Sinus Surgery (FESS). Emergence from anesthesia and extubation are often associated with undesirable airway reflexes such as coughing, bucking, laryngospasm, and marked hemodynamic fluctuations, which may adversely affect surgical outcomes and increase postoperative morbidity .

Hemodynamic instability during extubation may result in complications such as bleeding at the surgical site, myocardial ischemia, arrhythmias, and increased intracranial and intraocular pressure . These responses are particularly hazardous in FESS, where a bloodless surgical field is essential for optimal visualization and surgical success .

Several pharmacological agents has been studied to attenuate these responses, including opioids, beta blockers, local anesthetics, and α₂-adrenergic agonists . Lidocaine is commonly used to suppress airway reflexes during extubation, either intravenously or intratracheally, due to its local anesthetic effect on airway mucosa; however, its efficacy may be short-lived .

Dexmedetomidine is a highly selective α₂-adrenergic agonist that provides sedation, analgesia, and sympatholysis with minimal respiratory depression. It has been shown to attenuate stress responses during emergence and extubation more effectively than many traditional agents . Intratracheal administration of dexmedetomidine allows rapid absorption through the pulmonary circulation, leading to effective suppression of cough and hemodynamic responses .

Вмешательства

• Препарат dexmedetomidine Lidocaine Saline
  At the end of the surgery , the endotracheal tube cuff will be deflated and the study drug will be administered intratracheally. Manual positive pressure ventilation will be applied for drug distribution, followed by cuff reinflation

Первичные конечные точки

• Quality of extubation assessed by cough score at extubation . scored 0-5: 0 = No cough 1 = Occasional, single cough 2 = Mild, does not interfere with activities 3 = Moderate, interferes with activities 4 = Severe 5 = very sever. 0 is better 5 is worst [Срок оценки: at time of extubation]

Критерии участия

Критерии включения

• \- Age 18-60 years.
• Elective FESS under general anesthesia.
• ASA Physical Status I-II

Критерии исключения

• Allergy to dexmedetomidine or lidocaine
• Anticipated difficult airway
• Chronic pulmonary diseases (asthma, COPD)
• Uncontrolled hypertension or ischemic heart disease
• Patient refusal

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07504497 · Soh-Med-26-3-7MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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