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Набор скоро начнётся NCT06887998

The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.

Фаза III 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: Gabapentin 600 mg capsules, Gabapentin 400 mg capsules, Placebo.
Кому может быть актуально
Состояния в реестре: Emergence Agitation. Базовые параметры: 18 лет — 60 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Two Different Doses of Oral Gabapentin on Sevoflurane-associated Emergence Agitation and Delirium in Adult Patients After Nasal Surgery. A Prospective Controlled, Randomized, Double-blinded Study.

Обзор

Emergence agitation is a postanesthetic phenomenon that develops in the early phase of recovery from general anesthesia, and is characterized by agitation, disorientation, confusion, and possible violent behavior. Emergence agitation can cause serious events such as self-extubation, bleeding, catheter removal and even falling out of the bed leading to severe injuries . Furthermore, it may lead to injuries to health care providers and increase the demand on human resources. While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Emergence agitation is a common phenomenon occurring in 22.2% in adult patients undergoing general anesthesia for nasal surgery . Gabapentin, agamma-aminobutyricacidanalog, binds the voltage-gated calcium channels of the dorsal root ganglion, at α2-δ subunite. Gabapentin binding to these channels reduces the release of excitatory neurotransmitters preventing the propagation of painful stimuli which makes its use helpful in treatment of postoperative pain and agitation with less side effects compared with benzodiazepines and opioids . Gabapentin has been used in controlling acute perioperative conditions like preoperative anxiety, intraoperative attenuation of hemodynamic response to noxious stimuli and post operative pain, delirium and nausea and vomiting. A previous study examined the effect of oral gabapentin 600 mg in reducing emergence agitation in adult patients undergowing rhinoplasty, but this study will examine the effect of two different doses of oral gabapentin 400 mg and 600 mg in reducing emergence agitation after nasal surgery.

Вмешательства

  • Препарат Gabapentin 600 mg capsules
    21 patients will receive 600 mg oral gabapentin one hour before induction.
  • Препарат Gabapentin 400 mg capsules
    21 patients will receive 400 mg oral gabapentin one hour before induction.
  • Препарат Placebo
    21 patients will receive placepo one hour before induction.

Первичные конечные точки

  • Asessment of emergence agitation [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (9)
  • Duration of emergence [Срок оценки: through study completion, an average of 1 year]
  • Duration of Post Anesthesia Care Unit (PACU)stay [Срок оценки: through study completion, an average of 1 year]
  • Number of patients had Postoperative pain [Срок оценки: through study completion, an average of 1 year]
  • Number of patients required postoperative opioids and total dose. [Срок оценки: through study completion, an average of 1 year]
  • Number of patients had postoperative nausea and vomiting (PONV). [Срок оценки: through study completion, an average of 1 year]
  • 1. Heart rate [Срок оценки: through study completion, an average of 1 year]
  • systolic, diastolic and mean arterial blood pressure [Срок оценки: through study completion, an average of 1 year]
  • Oxygen saturation [Срок оценки: through study completion, an average of 1 year]
  • Duration of extubation [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing elective nasal surgery will be eligible for the study.

Критерии исключения

  • hypersensitivity to gabapentin
  • patient refusal
  • epilepsy
  • neurological or psychological conditions that impair communication.
  • current use of gabapentin, psychotropic or opioids medications.

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

Египет · 1 центр
  • Kasr Elainy Hospital , Cairo University — Cairo

Публикации

  • Badawy AA, Kasem SA, Rashwan D, Al Menesy T, Adel G, Mokhtar AM, Badawy YA. The role of Gabapentin oral solution in decreasing desflurane associated emergence agitation and delirium in children after stabismus surgery, a prospective randomized double-blind study. BMC Anesthesiol. 2018 Jun 20;18(1):73. doi: 10.1186/s12871-018-0533-5. PMID 29925328

Идентификаторы

NCT: NCT06887998 · gabapentin for agitation

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗