Идёт набор NCT06205355

Analgesia Nociception Index in Orthognathic Surgery

Без фазы С лечением Postoperative Pain

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: Analgesia/Nociception Index (ANI) monitoring, Standard monitoring.
Кому может быть актуально: Состояния в реестре: Postoperative Pain. Базовые параметры: от 18 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

Comparison of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) and Standard Analgesia During General Anesthesia in Patients Undergoing Orthognathic Surgery on Postoperative Quality of Recovery: a Prospective Randomized Controlled Trial

Обзор

This study aims to determine whether goal-directed analgesia using ANI(Analgesia/Nociception Index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery.

Вмешательства

Устройство Analgesia/Nociception Index (ANI) monitoring
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.
Устройство Standard monitoring
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision

Первичные конечные точки

Postoperative QoR-15K score [Срок оценки: 24 hours after the end of surgery]

Вторичные конечные точки (12)

Patient satisfaction [Срок оценки: 24 hours after the end of surgery]
intraoperative opioid consumption [Срок оценки: during surgery]
intraoperative non-opioid consumption [Срок оценки: during surgery]
intraoperative use of vasoactive drugs [Срок оценки: during surgery]
The time-weighted average of the segments of the total anesthesia time where the ANI value did not remain above 50 and below 70. [Срок оценки: during surgery]
Percentage of time with a deviation of more than ±20% from the mean blood pressure measured on the ward as a percentage of total anesthesia time [Срок оценки: during surgery]
estimated blood loss [Срок оценки: during surgery]
total fluid administration during surgery [Срок оценки: during surgery]
extubation time [Срок оценки: from the end of surgery to endotracheal tube extubation, up to 30 minutes]
number of participants with postoperative nausea vomiting [Срок оценки: 24 hours after the end of surgery]
number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence) [Срок оценки: 24 hours after the end of surgery]
Total postoperative opioid consumption [Срок оценки: 24 hours after the end of surgery]

Критерии участия

Критерии включения

Adult patients 18 or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia.
adult patients who can provide written informed consent to participate in the study, understand the procedures of this study, and be able to complete patient-reported questionnaires adequately.
adult patients who Have made an informed decision to participate in this study and have given written consent.