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Набор скоро начнётся NCT07601698

Dexmedetomidine vs Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anasthesia

Фаза IV С лечением Emergence Agitation

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: Dexmedetomidine, Propofol, Placebo.
Кому может быть актуально
Состояния в реестре: Emergence Agitation. Базовые параметры: 2 лет — 8 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

The Efficacy of Dexmedetomidine Versus Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anesthesia in Pediatric Ophthalmic Surgeries , A Prospective Randomized Comparative Controlled Study

Обзор

Primary we will Compare the Efficacy between Dexmedetomidine and "Propofol-lidocaine" mixture in preventing the post operative emergence agitation following sevoflurane anasthesia in pediatric ophthalmic surgeries Secondary we will evaluate time of extubation, time of orientation, Hemodynamic variables, Visual analog scale ( VAS), facial expressions scale , Adverse events

Подробное описание

Emergence agitation (EA) is a frequent and distressing complication in pediatric anesthesia, particularly following the use of volatile agents such as sevoflurane. It is characterized by restlessness, inconsolable crying, disorientation, and incongruent behavior during the early recovery period from general anesthesia (Dahmani S et al.,2014 ). Although EA is usually self-limited, it may cause harm to patients by leading to self-injury, disruption of surgical sites, removal of intravenous lines, or increased stress for caregivers and healthcare providers. The reported incidence of EA in children ranges between 10% and 80%, with higher prevalence observed in younger patients and in ophthalmic surgeries due to sensory deprivation and postoperative discomfort (Dahmani S et al.,2014 ). Sevoflurane remains the most widely used inhalational agent in pediatric anesthesia because of its rapid induction, low airway irritability, and favorable hemodynamic profile. However, it has been consistently associated with a higher risk of EA compared with other anesthetic techniques (Zhang Y et al., 2022) - (Liu J et al., 2022). Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has emerged as a promising agent due to its sedative, analgesic, and anxiolytic properties without significant respiratory depression (Zhang Y et al., 2022) - (Liu J et al., 2022). Several studies have demonstrated its efficacy in reducing the incidence and severity of EA when administered perioperatively (Zhang Y et al., 2022)- (Abdel-Ghaffar HS et al., 2019). On the other hand, propofol, a short-acting intravenous anesthetic with sedative and antiemetic properties, has also been investigated for EA prevention. When combined with lidocaine, propofol infusion provides not only smooth sedation and rapid recovery but also decreases pain associated with injection and potentially modulates airway reflexes and emergence agitation (Kim YH et al., 2014). Previous studies have shown that a single bolus dose of propofol at the end of surgery can reduce EA incidence in children undergoing ophthalmic surgery (Aouad MT t al., 2007). Meta-analyses further confirmed the beneficial role of propofol in reducing EA and improving recovery profiles (Liu J et al.,2022) -(Li Y et al.,2019). In ophthalmic surgeries for young children, smooth emergence from anesthesia is crucial, as agitation can compromise surgical outcomes, increase the risk of complications, and delay recovery (Kim YH et al., 2014)- (Aouad MT t al., 2007).

Вмешательства

  • Препарат Dexmedetomidine
    Dexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery
  • Препарат Propofol
    Propofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery.
  • Препарат Placebo
    receive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery

Первичные конечные точки

  • Incidence of emergence agitation [Срок оценки: Assessed at 5, 10, 15, and 30 minutes after extubation in the post-anesthesia care unit (PACU)]
Вторичные конечные точки (5)
  • Time to extubation [Срок оценки: From discontinuation of anesthesia until extubation, up to 30 minutes]
  • Time to orientation [Срок оценки: During recovery period in PACU, up to 30 minutes postoperatively]
  • Hemodynamic variables [Срок оценки: From baseline until 30 minutes postoperatively]
  • Postoperative pain score [Срок оценки: During the first 4 postoperative hours]
  • Adverse events [Срок оценки: During surgery and within the first 24 postoperative hours]

Критерии участия

Критерии включения

  • patients aged 2-8 years .
  • ASA physical status I-II.
  • Scheduled for elective surgeries under general anesthesia with sevoflurane

Критерии исключения

  • History of psychiatric illness or cognitive impairment.
  • Known allergy to study drugs.
  • Severe cardiovascular, hepatic, or renal disease.
  • Chronic use of sedatives or opioids.

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07601698 · EA in sevofluran in anesthesia

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗