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Идёт набор NCT07746505

Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery

— Наблюдательное General Anesthesia Aged Intraoperative Hypotension Anxiety

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: General Anesthesia, Aged, Intraoperative Hypotension, Anxiety. Базовые параметры: от 65 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
Китай
Следующий шаг
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Официальное название

Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study

Обзор

This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.

Подробное описание

This is a prospective, observational, cohort study. The exposure is the benzodiazepine sedative actually used at induction; patients are grouped as the remimazolam (RM) or midazolam (MZ) cohort based on the clinical record. Induction and maintenance are individualized by the attending anesthesiologist ; investigators only observe and collect data without altering routine care. All patients receive standard monitoring (ECG, SpO₂, non-invasive/invasive blood pressure, end-tidal CO₂, anesthetic depth). Collected data include demographics, medical history and risk factors, medication history, examination and laboratory results, and intraoperative variables (ASA class, surgery type and duration, hypotension, anesthetic and opioid doses, fluid balance, blood loss, transfusion).

Первичные конечные точки

  • Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline) [Срок оценки: From anesthetic induction through the end of surgery (intraoperative period)]
Вторичные конечные точки (7)
  • Vasoactive drug requirement [Срок оценки: Induction period and entire perioperative period Cumulative dose and frequency of vasoactive agents]
  • Time to Extubation [Срок оценки: During anesthesia emergence]
  • Quality of Recovery at 24 Hours Postoperatively as Assessed by the Quality of Recovery-15 (QoR-15) Questionnaire [Срок оценки: 24 hours after surgery]
  • Perioperative Anxiety Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [Срок оценки: Day of surgery and postoperative day 2]
  • Composite of Major Organ Complications (Postoperative Delirium, Acute Kidney Injury, Stroke, Acute Myocardial Infarction, Pulmonary Infection, In-Hospital All-Cause Mortality, Postoperative Length of Stay, and Unplanned Reoperation) [Срок оценки: From the end of surgery until hospital discharge, an average of 7 days]
  • Incidence of Anesthesia-Related Adverse Events (Composite) [Срок оценки: perioperative]
  • Length of Stay in the Post-Anesthesia Care Unit (PACU) [Срок оценки: From PACU admission until PACU discharge readiness, assessed up to 24 hours after surgery]

Критерии участия

Критерии включения

  • Age 65 years or older.
  • Scheduled for elective non-cardiac surgery under general anesthesia.
  • American Society of Anesthesiologists physical status I to IV.
  • Planned airway management with tracheal intubation or a laryngeal mask airway.
  • Written informed consent provided by the participant or the participant's legally authorized representative.

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Критерии исключения

  • Long-term preoperative benzodiazepine use.
  • Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.
  • History of drug abuse or alcoholism within the past 2 years.
  • No preoperative cognitive assessment available.
  • Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18.

7.Refusal to provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Zhejiang University School of Medicin — Ханчжоу

Идентификаторы

NCT: NCT07746505 · 2026-0835

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗