- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07302815
Превентивное внутривенное введение микродозы дексмедетомидина для предотвращения ажитации пробуждения у взрослых пациентов, переносящих септопластику
Превентивное внутривенное введение микродоз дексмедетомидина для предотвращения послеоперационного возбуждения у взрослых пациентов, переносящих септопластику: рандомизированное плацебо-контролируемое исследование
This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Emergence agitation (EA) is characterised by confusion, restlessness or aggressive behaviour during recovery from general anaesthesia. EA is more common following ear, nose, & throat (ENT) surgery. The exact cause and pathophysiology of EA are unknown, although risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, otolaryngology operations, and the use of inhalational anesthetics particularly sevoflurane. EA might cause injury, accidental removal of intravenous cannulation, self-extubation, post-operative wound bleeding and increase the nursing requirements in the post-anesthesia care unit (PACU). There are limited studies concerning adult EA, and although its prevalence is less than child EA, it carries more risk of injury due to serious uncontrolled behaviors. Intravenous (IV) anesthetics, sedatives and opioids are the most frequently utilized medications to manage EA, with variable success rates and significant potential to delay recovery and cause undesirable side-effects. Dexmedetomidine is a highly selective α2 agonist which produces sedation and anxiolysis through reduction in sympathetic central nervous system activity. It has a major advantage over other sedatives; it is associated with minimal respiratory depression. According to a recent meta-analysis, intraoperative administration of dexmedetomidine decreases postoperative pain and the incidence of EA in adults. Considering the short length of corrective nasal reduction surgery (CR), an intraoperative infusion of dexmedetomidine as an anesthetic adjuvant may prolong the anesthesia and recovery time. Low dose infusion of dexmedetomidine (0.2 µg /kg/h) has been reported to reduce incidence of EA and opioid consumption effectively in elderly patients undergoing cancer surgeries under GA. Previous studies have shown that a single dose of dexmedetomidine, not as a premedication, is also effective in reducing EA and facilitating smooth extubation after pediatric adenotonsillectomy. Also recent study reported the efficacy of pre-operative dexmedetomidine administration (1 μg/kg) in preventing EA in adults undergoing CR of a nasal bone fracture. Up till now no clinical studies investigated the efficacy of single pre-operative micro dose of dexmedetomidine in prevention of EA, so in this clinical study we hypothesize that preoperative micro dose of dexmedetomidine may be beneficial in mitigation of EA in short timed Septoplasty surgeries safely and without prolongation of recovery time.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Gharbia Governorate
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Tanta, Gharbia Governorate, Египет, 31527
- Tanta university
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adult patients of both gender aged 18 to 60 years with American Society of Anesthesiologists (ASA) Physical Status I or II, who were scheduled for septoplasty surgery under general anesthesia.
Exclusion Criteria:
- Patients declined to participate in the trial.
- History or clinical evidence of chronic obstructive pulmonary disease.
- History of renal or hepatic dysfunction, sleep apnea syndrome.
- Cognitive dysfunction or psychiatric disorder.
- Patients receiving beta blocker.
- Patients with anticipated difficult airway.
- Patients with electro cardiac abnormalities.
- Emergency surgeries.
- Pregnancy.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Dexmedetomidine group
60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery. |
micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery. |
|
Плацебо Компаратор: Control group
60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery. |
50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of emergence agitation
Временное ограничение: incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.
|
using Aono's Four-Point Scale (Aono Scale) which is a simple and widely used tool to assess emergence agitation (EA). It categorizes agitation during emergence from anesthesia into four levels.
Scores 3-4 indicate clinically relevant emergence agitation. |
incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
severity of emergence agitation
Временное ограничение: severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.
|
Aono's Scale grades the intensity of a patient's agitation during emergence from anesthesia (3) Moderately agitated - Patient is crying or difficult to console but not combative. (4) Severely agitated - Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff. |
severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.
|
|
extubation time
Временное ограничение: Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).
|
Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT). |
Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).
|
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Length of stay in the post anesthetic care unit (PACU).
Временное ограничение: time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward
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Total time a patient spends in the PACU from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward |
time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward
|
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Intraoperative opioid consumption
Временное ограничение: from induction of anesthesia until completion of surgery
|
Total amount of opioid medications administered to a patient during the entire surgical procedure, from induction of anesthesia until completion of surgery |
from induction of anesthesia until completion of surgery
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Post operative numerical rating scale score (NRS)
Временное ограничение: - NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery
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The Numerical Rating Scale (NRS) is a validated tool used to assess a patient's pain intensity by having them assign a number to their pain on a 0-10 scale. On a scale from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable |
- NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.
- Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.
- Kim JC, Kim J, Kwak H, Ahn SW. Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 7;19(1):144. doi: 10.1186/s12871-019-0816-5.
- Lee HS, Yoon HY, Jin HJ, Hwang SH. Can Dexmedetomidine Influence Recovery Profiles from General Anesthesia in Nasal Surgery? Otolaryngol Head Neck Surg. 2018 Jan;158(1):43-53. doi: 10.1177/0194599817733735. Epub 2017 Sep 26.
- Abdelaziz TSA, Mohammed Elsayed HE, Kamal Eldin DM, Ibrahim IM. "The effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty". A prospective, randomized, double-blind controlled trial. BMC Anesthesiol. 2025 Jan 31;25(1):50. doi: 10.1186/s12871-025-02914-5.
- Zhu W, Sun J, He J, Zhang W, Shi M. A Randomized Controlled Study of Caudal Dexmedetomidine for the Prevention of Postoperative Agitation in Children Undergoing Urethroplasty. Front Pediatr. 2021 Sep 29;9:658047. doi: 10.3389/fped.2021.658047. eCollection 2021.
- Al Mutair A, Alabbasi Y, Alshammari B, Alrasheeday AM, Alharbi HF, Aleid AM. A Meta-Analysis of the Impact of Intranasal Dexmedetomidine on Emergence Delirium and Agitation in Children and Adolescents Undergoing Tonsillectomy and/or Adenoidectomy. J Clin Med. 2025 Feb 26;14(5):1586. doi: 10.3390/jcm14051586.
- Cole JW, Murray DJ, McAllister JD, Hirshberg GE. Emergence behaviour in children: defining the incidence of excitement and agitation following anaesthesia. Paediatr Anaesth. 2002 Jun;12(5):442-7. doi: 10.1046/j.1460-9592.2002.00868.x.
- Tolly B, Waly A, Peterson G, Erbes CR, Prielipp RC, Apostolidou I. Adult Emergence Agitation: A Veteran-Focused Narrative Review. Anesth Analg. 2021 Feb 1;132(2):353-364. doi: 10.1213/ANE.0000000000005211.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Заболевания нервной системы
- Психические расстройства
- Послеоперационные осложнения
- Патологические процессы
- Путаница
- Нейроповеденческие проявления
- Нейрокогнитивные расстройства
- Бред
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Эмерджентный бред
- Гетероциклические соединения, 1-кольцо
- Гетероциклические соединения
- Азолы
- Имидазолы
- Неорганические химические вещества
- Хлорные соединения
- Соединения натрия
- Хлориды
- Соляная кислота
- Дексмедетомидин
- Хлорид натрия
Другие идентификационные номера исследования
- 36264PR131061/11/25
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The data will be available upon a reasonable request from the corresponding author
Сроки обмена IPD
The data will be available upon a reasonable request from the corresponding author after the end of the study for one year
Критерии совместного доступа к IPD
The data will be available upon a reasonable request from the corresponding author
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
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. .