ENDOTRACHEAL Tube LIDOCAINE (ETT LIDOCAINE)
Application of a 5% Lidocaine Ointment to Endotracheal Tubes to Reduce Emergence Bucking: a Randomized Double-Blind Prospective Trial.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Emergence coughing or bucking is a common complication of general anesthesia with endotracheal intubation and may result in clinically significant increases in hemodynamic stress, airway irritation, postoperative discomfort, and potential complications. Although multiple pharmacologic strategies have been evaluated to reduce emergence coughing, the effectiveness of topical lidocaine preparations applied to the endotracheal tube remains uncertain.
This prospective, randomized, double-blind, two-arm clinical trial will evaluate whether applying 5% lidocaine ointment to the external surface of the endotracheal tube before intubation reduces coughing or bucking during emergence from general anesthesia compared with standard water-based endotracheal tube lubricant.
Adult patients undergoing elective surgical procedures requiring general anesthesia with oral endotracheal intubation will be randomized to receive either 5% lidocaine ointment or standard water-based lubricant applied to the external surface of the endotracheal tube immediately prior to intubation. The study will use standardized anesthetic management, double-blinding procedures, and consistent outcome assessment methods.
The primary outcome is the incidence of coughing or bucking during emergence from anesthesia, assessed from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube. Secondary outcomes include the incidence and severity of postoperative sore throat and hoarseness at defined postoperative time points, as well as total intraoperative opioid administration converted to morphine milligram equivalents.
Additional demographic and procedural information, including age, sex, body mass index, American Society of Anesthesiologists physical status, airway assessment characteristics, duration of intubation, and surgical procedure type, will be collected to describe the study population and evaluate potential factors associated with outcomes.
The study aims to determine whether 5% lidocaine ointment provides a clinically useful strategy for reducing emergence-related airway irritation and improving postoperative airway comfort compared with standard endotracheal tube lubrication.
Тип исследования
Регистрация (Оцененный)
Фаза
- Ранняя фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Ling-Qun Hu, MD
- Номер телефона: 6142933559
- Электронная почта: lingqun.hu@osumc.edu
Места учебы
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43201
- Рекрутинг
- The Ohio State University Wexner Medical Center
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Контакт:
- Ling-Qun Hu
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Контакт:
- Ling-Qun Hu, MD
- Номер телефона: 614-293-3559
- Электронная почта: lingqun.hu@osumc.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Adults aged 18 years and older, with an upper age limit of 90 years, scheduled for surgery requiring general anesthesia with an oral endotracheal tube.
Patients undergoing general surgical procedures, including but not limited to abdominal surgeries (e.g., hernia repairs, cholecystectomy, appendectomy, bowel surgery), non-cervical spinal surgeries, craniotomies, orthopedic procedures, urologic procedures, and other procedures meeting the inclusion criteria.
American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV. Patients able to provide informed consent.
Exclusion Criteria:
Age younger than 18 years or older than 90 years. Patients undergoing procedures requiring a specialized airway device instead of a standard oral endotracheal tube (e.g., laryngeal mask airway, double-lumen endobronchial tube).
Patients with known hypersensitivity or allergy to amide local anesthetics. Patients with pre-existing sore throat, upper respiratory infection, or active cough at baseline.
Patients requiring postoperative mechanical ventilation or critically ill patients requiring intensive care.
Patients unable to adequately report outcomes or participate in follow-up assessments.
Current smokers. Pregnant women. Prisoners.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 5% Lidocaine Ointment
Participants randomized to this arm will receive 5% lidocaine ointment applied to the external surface of the endotracheal tube immediately prior to endotracheal intubation.
The ointment will be applied according to the study protocol before induction of general anesthesia.
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A 5% lidocaine ointment will be applied as a thin, uniform layer to the external surface of the endotracheal tube immediately before endotracheal intubation.
The ointment will be applied once according to the study protocol before induction of general anesthesia.
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Активный компаратор: Water-Based Lubricant
Participants randomized to this arm will receive the institution's standard water-based lubricant applied to the external surface of the endotracheal tube immediately prior to endotracheal intubation. The lubricant will be applied according to routine clinical practice before induction of general anesthesia. These entries are appropriate because both treatments are established clinical practices, with the investigational intervention being compared against an active standard-of-care comparator. |
Institutional standard water-based endotracheal tube lubricant will be applied to the external surface of the endotracheal tube immediately before endotracheal intubation according to routine clinical practice before induction of general anesthesia.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Incidence of Coughing or Bucking During Emergence from General Anesthesia
Временное ограничение: From initiation of emergence from anesthesia until endotracheal tube removal, assessed during the extubation period (approximately 5-30 minutes after anesthetic reduction).
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The incidence of coughing or bucking occurring during emergence from anesthesia, defined as any cough or bucking movement from the time anesthetic agents are reduced for extubation until removal of the endotracheal tube.
The outcome will be assessed by direct observation and recorded as the presence or absence of coughing/bucking and the number of bucking episodes using a standardized assessment.
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From initiation of emergence from anesthesia until endotracheal tube removal, assessed during the extubation period (approximately 5-30 minutes after anesthetic reduction).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Incidence and Severity of Postoperative Sore Throat
Временное ограничение: 2 hours and 24 (±3) hours after extubation.
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Incidence and severity of postoperative sore throat will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Moderate or severe sore throat will be considered clinically significant for analysis.
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2 hours and 24 (±3) hours after extubation.
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Incidence and Severity of Postoperative Hoarseness
Временное ограничение: 2 hours and 24 (±3) hours after extubation.
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Incidence and severity of postoperative hoarseness will be assessed using a patient-reported 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Moderate or severe hoarseness will be considered clinically significant for analysis.
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2 hours and 24 (±3) hours after extubation.
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Total Intraoperative Opioid Use
Временное ограничение: From induction of anesthesia until endotracheal tube removal during the intraoperative period.
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Total opioid administration from induction of anesthesia until extubation, converted to morphine milligram equivalents (MME) for analysis.
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From induction of anesthesia until endotracheal tube removal during the intraoperative period.
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- STUDY20260673
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .