The Effect of Dexmedetomidine Versus Lidocaine on 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, Lidocaine.
- 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 Intravenous Dexmedetomidine Versus Intravenous Lidocaine on the Emergence Agitation After Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.
Обзор
The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.
Подробное описание
Endoscopic sinus surgery (ESS) is a common operation for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical therapy alone is insufficient .
Early recovery from general anesthesia is accompanied by agitation, confusion, disorientation, and violent behavior, which is known as Emergence Agitation (EA). This post-anesthetic issue occurs in the early stages of General Anesthesia (GA) recovery, posing challenges in terms of both patient recovery delay and the complexities associated with assessment and management.
The incidence of EA varies, from approximately 0.25% to 90.5%, with age, assessment tool used, definitions, anesthetic techniques, type of surgery, and time of EA assessment during recovery .
Because the airway is contaminated with blood and the nasal airway is closed with surgical packs. ENT surgery is linked to a higher incidence of emerging agitation after nasal surgery.
Although EA is commonly self-limited and happens within the first 30 min of stay in a postanesthesia care unit (PACU) and also can lead to disconnection of monitoring devices or intravenous catheters, physical damage, falling, increase in the risk of bleeding, and self-extubation .
Several pharmacological methods have been used to mitigate EA, including opioid (fentanyl, remifentanil), propofol, benzodiazepine (midazolam), α2- aderenoreceptor agonist (clonidine, dexmedetomidine), and N-methy-d-aspar- tate (NMDA) receptor antagonist (ketamine, magnesium sulfate) administration.
Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life, and a favorable safety profile, and is therefore the LA of choice for continuous IV administration. Systemic lidocaine has been shown to be an effective adjunct strategy to reduce postoperative pain.
Dexmedetomidine is known as a highly selective α (2)-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, and analgesic-sparing effects, which causes minimal depression of the respiratory function.
Вмешательства
- Препарат Dexmedetomidine
Group (D) recieves Dexmedetomidine bolus 1mcg/kg over 10 minutes before induction of anesthesia followed by continous infusion at 0.4 mcg/kg/h until the end of surgery - Препарат Lidocaine
Group (L) recieves IV lidocaine 1.5 mg/kg slowly before induction of anesthesia then lidocaine infusion starts at a rate of 2mg/kg/h
Первичные конечные точки
- Incidence of emergence agitation (EA) . [Срок оценки: Immediate after extubation]
Вторичные конечные точки (12)
- heart rate (beats per minute ) [Срок оценки: baseline ( preoperative )]
- heart rate (beats per minute ) [Срок оценки: after 30 minutes ( intraoperative)]
- heart rate (beats per minute) [Срок оценки: after 60 minutes ( intraoperative )]
- heart rate (beats per minute) [Срок оценки: 0 hour postoperative]
- heart rate (beats per minute) [Срок оценки: 1 hour postoperative]
- heart rate (beats per minute) [Срок оценки: 3 hours postoperative]
- heart rate (beats per minute) [Срок оценки: 6 hours postoperative]
- heart rate (beats per minute) [Срок оценки: 12 hours postoperative]
- heart rate (beats per minute) [Срок оценки: 24 hours postoperative]
- Mean arterial blood pressure (mmHg) [Срок оценки: baseline ( preoperative )]
- Mean arterial blood pressure (mmHg) [Срок оценки: after 30 minutes ( intraoperative )]
- Mean arterial blood pressure (mmHg) [Срок оценки: after 60 minutes ( intraoperative )]
Критерии участия
Критерии включения
- Age : 18-60
- ASA Physical Status I or II
- Elective endoscopic sinus surgery under general anesthesia .
Критерии исключения
- Refusal to participate
- Mental retardation or inability to communicate
- Allergy to anesthetics or study medications .
- Chronic use of beta blockers .
- significant hepatic, neurologic, cardiovascular or respiratory disease .
- BMI>35 kg/m2
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
Египет · 1 центр
- FayoumU — Al Fayyum
Публикации
- Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90. PMID 25535538
- Lourijsen ES, Reitsma S, Vleming M, Hannink G, Adriaensen GFJPM, Cornet ME, Hoven DR, Videler WJM, Bretschneider JH, Reinartz SM, Rovers MM, Fokkens WJ. Endoscopic sinus surgery with medical therapy versus medical therapy for chronic rhinosinusitis with nasal polyps: a multicentre, randomised, controlled trial. Lancet Respir Med. 2022 Apr;10(4):337-346. doi: 10.1016/S2213-2600(21)00457-4. Epub 202 PMID 35012708
Идентификаторы
NCT: NCT07355049 · M786