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Набор скоро начнётся NCT07381036

Comparison of Nebulized Ketamine With Nebulized Magnesium Sulfate for the Prevention of Postoperative Sore Throat

Без фазы С лечением Postoperative Sore Throat

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ketamine nebulizer, Mg sulfate nebulizer, Placebo.
Кому может быть актуально
Состояния в реестре: Postoperative Sore Throat. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of Nebulized Ketamine With Nebulized Magnesium Sulfate for the Prevention of Postoperative Sore Throat in Adult Surgical Patients Undergoing General Anesthesia: Prospective Randomized Controlled Study

Обзор

The aim of this study is to compare the efficacy of nebulized ketamine versus nebulized magnesium sulfate in reducing the incidence and severity of POST. * Primary outcome • To compare the incidence of POST method. * Secondary outcomes * Onset, Severity, and duration of POST at 0, 2, 4, 6, 12, 24 hours postoperative. * The hemodynamics recording (HR, BP, MBP, pre and post nebulization) * Adverse Effects (e.g., sedation, cough, nausea, vomiting, ….)

Подробное описание

Post-operative sore throat (POST) is a common complication seen in patients after general anesthesia with endotracheal intubation although clinicians often regard it as a minor complication. The incidence of POST is estimated to be 21%-65% in different studies . The primary cause of POST is airway irritation and inflammation or trauma caused by an endotracheal tube; however, the airway may be extremely sensitive due to a preexisting comorbid condition. Regardless of its incidence and some preventive measures, POST is listed from the top as patients' most undesirable outcome in the postoperative period. POST is well recognized that reporting of sore throat is affected by the method of questioning that is whether the questions asked directly or indirectly .

The expression of POST constitutes a number of signs and symptoms. For example, sore throat is an ordinary expression of pharyngitis, which by itself can have a number of causes. It may also include a variety of symptoms including pain and discomfort, laryngitis, tracheitis, hoarseness, cough, or dysphagia. This leads to an increase in morbidity and causes further complications in patients .

Various pharmacological and nonpharmacological methods have been tried to decrease the incidence of POST with varying success rates. The pharmacological methods used for the prevention of POST are the use of inhalational, intravenous or topical agents that include beclomethasone gel, magnesium sulfate gargle, ketamine gargle, nebulized ketamine, magnesium sulfate nebulization, and lidocaine spray .

Nebulized medication administration is strongly recommended over intranasal delivery that is inhaled into the lungs and respiratory tract and is an important strategy for various respiratory problems and diseases. It reduces cough, temporary nasal discomfort, and vocal cord irritation. N-methyl-D-aspartate (NMDA) receptors had a crucial part in inflammation and nociception in the body. NMDA receptors exist in both peripheral nervous system (PNS) neurons and the central NS (CNS) .

Ketamine, an NMDA receptor antagonist, is commonly administered as a nebulizer to decline the severity and frequency of POST owing to its antinociceptive and anti-inflammatory properties .

Magnesium is also another NMDA receptor antagonist that plays a significant role in decreasing the incidence of POST. It is used as nebulizer; it is accessible and easily available in hospitals. The efficacy of preoperative nebulization of magnesium sulfate was assessed and found that the incidence and severity of POST were reduced at rest and on swallowing through 24 hours post extubation (8). Some studies showed that ketamine and magnesium can be used for attenuation of postoperative sore throat .

Вмешательства

  • Препарат Ketamine nebulizer
    50 patients will receive preoperative nebulization with 50 mg ketamine in 5 ml normal saline.
  • Препарат Mg sulfate nebulizer
    50 patients will receive preoperative nebulization with 250 mg magnesium sulfate in 5 ml normal saline.
  • Препарат Placebo
    50 patients will receive preoperative nebulization with 5 ml normal saline.

Первичные конечные точки

  • To compare the incidence of Post operative sore throat method. [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • Age from 18 to 65 years old.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Elective surgery requiring GA with endotracheal intubation.

\- Exclusion Criteria:

  • Surgery involves the oral cavity, nasopharynx, larynx, and neck regions.
  • Surgery requires prone position.
  • Surgery lasted more than 3 hours.
  • History of preoperative sore throat, common cold.
  • Anticipated difficult airway.
  • Any known allergies to study drugs.
  • Recent non-steroidal anti-inflammatory drugs use.
  • Pregnancy.

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
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07381036 · Soh-Med-25-12-7MS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗