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Набор скоро начнётся NCT07749079

Risk Factors for Postoperative Nausea and Vomiting After Nasal Surgery Under General Anesthesia

Наблюдательное PONV

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: PONV. 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
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

Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Nasal Surgery Under General Anesthesia: A Multicenter Prospective Observational Cohort Study

Обзор

The goal of this observational study is to learn how often postoperative nausea and vomiting occur in adults undergoing nasal surgery under general anesthesia and to identify factors associated with these events. The study will also describe other postoperative complications and factors that may affect recovery. The main questions it aims to answer are: * How many participants experience nausea, retching, or vomiting within 24 hours after surgery? * Which patient characteristics, anesthesia-related factors, surgical factors, and perioperative medications are associated with postoperative nausea and vomiting? * What other postoperative complications and nasal-related symptoms occur after surgery? Approximately 1,000 adults undergoing nasal surgery under general anesthesia at three hospitals in China will be enrolled. This is an observational study, and participation will not change the anesthesia, surgery, medications, or other medical care selected by the treating clinical team. Participants will: * Complete assessments before surgery about their medical history, previous nausea or vomiting, anxiety, sleep, and recovery status * Receive routine anesthesia and surgical care * Be assessed for nausea, retching, vomiting, pain, nasal discomfort, and other complications during the first 24 hours after surgery * Complete follow-up assessments after surgery, including follow-up by telephone after discharge, for up to 6 months The study will use information from participant questionnaires, medical records, anesthesia records, and postoperative follow-up assessments.

Подробное описание

This multicenter, prospective observational cohort study will evaluate postoperative nausea and vomiting in adults undergoing nasal surgery under general anesthesia at three hospitals in China. The study is designed to characterize the occurrence, timing, and severity of postoperative nausea and vomiting and to examine associations with patient-related, anesthesia-related, surgical, and perioperative management factors.

No study-specific treatment or change to routine clinical care will be required. Decisions regarding anesthetic technique, airway management, analgesia, antiemetic prophylaxis, fluid administration, surgical management, and postoperative treatment will be made by the clinical team according to usual practice at each participating center.

Data will be collected prospectively from participant interviews and questionnaires, medical records, anesthesia information systems, case report forms, and postoperative follow-up assessments. Preoperative data will include demographic and clinical characteristics, previous postoperative or post-discharge nausea and vomiting, motion sickness history, comorbidities, medication history, smoking and alcohol history, anxiety and depression, sleep quality, fasting duration, and baseline recovery status.

Perioperative data will include the type and duration of surgery, anesthetic and analgesic medications, antiemetic use, airway management, intraoperative fluids, physiologic measurements, adverse events, surgical field conditions, blood loss, and nasal surgery-specific factors such as nasal packing and procedure-related characteristics.

After surgery, participants will be assessed for nausea, retching, vomiting, use and response to rescue antiemetics, pain, fatigue, sleep quality, respiratory events, and nasal-related discomfort. Postoperative nausea and vomiting will be evaluated during prespecified intervals within the first 24 hours after surgery. Additional follow-up will assess post-discharge nausea and vomiting, postoperative complications, pain, sleep, psychological status, and nasal symptoms through telephone or in-person assessments for up to 6 months.

The collected data will be used to estimate the incidence of postoperative nausea and vomiting and to explore independent risk factors using multivariable statistical models. The study will also establish a prospective perioperative database to support future risk-prediction research and optimization of perioperative care for patients undergoing nasal surgery.

Первичные конечные точки

  • Incidence of Postoperative Nausea and Vomiting Within 24 Hours [Срок оценки: From the end of surgery through 24 hours after surgery]
Вторичные конечные точки (12)
  • Incidence of Clinically Significant Postoperative Nausea and Vomiting [Срок оценки: At 6 hours, 24 hours, and postoperative day 3]
  • Incidence of Vomiting or Retching Within 24 Hours [Срок оценки: From the end of surgery through 24 hours after surgery]
  • Number of Vomiting or Retching Episodes Within 24 Hours [Срок оценки: From the end of surgery through 24 hours after surgery]
  • Use of Rescue Antiemetic Medication [Срок оценки: From the end of surgery through postoperative day 3]
  • Severity of Postoperative Pain [Срок оценки: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30]
  • Postoperative Nasal and Related Symptoms [Срок оценки: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30]
  • Postoperative Fatigue at Discharge [Срок оценки: At hospital discharge, anticipated within 3 days after surgery]
  • Postoperative Short-term Sleep Quality [Срок оценки: At 24 hours, postoperative day 3, and postoperative day 30]
  • Postoperative Longer-term Sleep Quality [Срок оценки: At 24 hours, postoperative day 3, and postoperative day 30]
  • Incidence of Postoperative Pulmonary Complications [Срок оценки: Through postoperative day 30]
  • Incidence of respiratory adverse events [Срок оценки: Within 24 hours, through postoperative day 3, and through postoperative day 30]
  • Incidence of airway rescue interventions [Срок оценки: Within 24 hours]

Критерии участия

Критерии включения

  • Scheduled to undergo nasal surgery under general anesthesia
  • Aged 18 years or older
  • Willing and able to provide written informed consent

Критерии исключения

  • Unable to cooperate with study procedures or complete study assessments for any reason, including language barriers, cognitive impairment, or inability to complete the questionnaires
  • Considered unsuitable for participation by the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07749079 · ENTPONV-2026152

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗