Набор скоро начнётся NCT07740655

Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery

Фаза IV С лечением Emergence Agitation General Anesthesia Nasal Surgical Procedures

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: Remimazolam.
Кому может быть актуально: Состояния в реестре: Emergence Agitation, General Anesthesia, Nasal Surgical Procedures. Базовые параметры: 18 лет — 79 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: South Korea
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

Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery Under Sevoflurane Anesthesia: A Randomized Double-blind Non-inferiority Trial

Обзор

Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery. Although remimazolam 0.1 mg/kg has been shown to reduce the incidence of EA, this dose may produce excessive sedation and increase the risk of intraoperative burst suppression. This randomized, double-blind, non-inferiority trial will compare low-dose remimazolam (0.03 mg/kg) with the standard dose (0.1 mg/kg) administered at the end of surgery in adult patients undergoing nasal surgery under sevoflurane anesthesia. The primary objective is to determine whether low-dose remimazolam is non-inferior to the standard dose in preventing emergence agitation. Secondary outcomes include burst suppression, recovery profiles, and safety outcomes.

Подробное описание

Emergence agitation (EA) is characterized by confusion, agitation, and non-purposeful movements during recovery from general anesthesia. In adult patients undergoing nasal surgery with sevoflurane anesthesia, EA occurs frequently and may result in self-injury, accidental removal of medical devices, postoperative bleeding, prolonged recovery, and increased healthcare burden.

Remimazolam is an ultra-short-acting benzodiazepine that is rapidly metabolized by tissue esterases and can be antagonized with flumazenil. Previous studies have demonstrated that intravenous administration of remimazolam 0.1 mg/kg at the end of surgery reduces the incidence of EA after nasal surgery. However, this dose may produce deeper-than-necessary sedation and increase the occurrence of burst suppression, which has been associated with postoperative delirium.

The present study aims to evaluate whether a lower dose of remimazolam (0.03 mg/kg), corresponding to the supplemental dose commonly used for procedural sedation, can preserve the preventive effect on EA while reducing excessive electroencephalographic suppression and improving recovery characteristics.

This is a prospective, randomized, double-blind, non-inferiority trial conducted at Jeju National University Hospital. Adult patients scheduled for nasal surgery under sevoflurane anesthesia will be randomly assigned in a 1:1 ratio to receive either remimazolam 0.03 mg/kg or remimazolam 0.1 mg/kg immediately after discontinuation of sevoflurane at the end of surgery.

The primary outcome is the incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater. Secondary outcomes include the incidence and duration of burst suppression assessed using the SedLine monitor, Patient State Index (PSi), extubation time, post-anesthesia care unit (PACU) length of stay, and safety outcomes including hypoxemia, hypotension, flumazenil administration, and other adverse events.

Вмешательства

Препарат Remimazolam
Remimazolam will be administered intravenously immediately after discontinuation of sevoflurane at the end of surgery. Participants will receive either 0.03 mg/kg or 0.1 mg/kg according to randomized treatment allocation.

Первичные конечные точки

Incidence of emergence agitation [Срок оценки: Within 15 minutes after extubation]

Вторичные конечные точки (3)

Incidence of burst suppression [Срок оценки: From study drug administration until extubation(up to 30 minutes)]
Duration of burst suppression [Срок оценки: From study drug administration until extubation(up to 30 minutes)]
Lowest Patient State Index (PSI) [Срок оценки: From study drug administration until extubation(up to 30 minutes)]

Критерии участия

Критерии включения

Adults aged 18 to 79 years.
Scheduled to undergo elective nasal surgery under sevoflurane-based general anesthesia at Jeju National University Hospital.
Able to provide written informed consent.