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Набор скоро начнётся NCT07529795

Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Emergency Surgery for Peritonitis

Фаза IV С лечением Secondary Peritonitis Post-induction Hypotension

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: Norepinephrine (0.05 μg/kg/min), Placebo.
Кому может быть актуально
Состояния в реестре: Secondary Peritonitis, Post-induction Hypotension. 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
Вьетнам
Следующий шаг
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Официальное название

Protocolized Low-dose Norepinephrine Infusion for Prevention of Post-induction Hypotension in Adults Undergoing Emergency Surgery for Secondary Peritonitis: A Randomized Double-blind Placebo-controlled Trial

Обзор

This study tests whether giving a low-dose norepinephrine infusion just before induction of anesthesia can reduce low blood pressure during emergency surgery for peritonitis. Adults with secondary peritonitis who are scheduled for emergency surgery and have stable blood pressure after initial resuscitation will be randomly assigned to receive either norepinephrine or placebo (normal saline) during induction of anesthesia. The main outcome is the cumulative time spent with mean arterial pressure (MAP) below 65 mmHg from the start of propofol administration to 10 minutes after endotracheal intubation. The study will also evaluate rescue vasopressor use, heart rate changes, drug-related adverse events, and selected early postoperative outcomes.

Подробное описание

The study is a single-center, randomized, double-blind, placebo-controlled interventional trial conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam.

Adults undergoing emergency surgery for secondary peritonitis often have marked hemodynamic vulnerability during induction of general anesthesia because of systemic inflammation, vasodilation, capillary leak, and relative hypovolemia. Propofol-based induction may further reduce arterial pressure and organ perfusion in this setting.

Participants who meet eligibility criteria and have a mean arterial pressure (MAP) of at least 65 mmHg after initial resuscitation, without ongoing vasopressor support, will be enrolled and randomized 1:1 to a norepinephrine infusion group or a placebo group.

In the intervention group, norepinephrine will be infused at 0.05 micrograms/kg/min starting 3 minutes before fentanyl. In the placebo group, 0.9% sodium chloride will be infused with the same presentation, timing, and pump settings.

All participants will undergo a standardized induction protocol with fentanyl, titrated propofol, rocuronium, arterial line monitoring before induction, and protocolized hemodynamic rescue treatment.

The primary endpoint is the cumulative duration of MAP below 65 mmHg during the induction-intubation window, defined from the start of propofol administration to 10 minutes after endotracheal intubation. Secondary endpoints include the incidence of MAP below 65 and below 55 mmHg, the largest decrease in MAP from baseline, heart-rate changes, rescue vasopressor requirements, atropine use, and predefined early postoperative outcomes.

Вмешательства

  • Препарат Norepinephrine (0.05 μg/kg/min)
    Norepinephrine prepared in a blinded syringe and infused continuously at 0.05 micrograms/kg/min starting 3 minutes before fentanyl during induction of general anesthesia. Infusion is adjusted or temporarily stopped according to the protocol-defined hemodynamic safety algorithm.
  • Другое Placebo
    Placebo: 0.9% Sodium Chloride prepared in a blinded syringe and administered with the same timing, presentation, and pump settings as the active study drug.

Первичные конечные точки

  • Cumulative duration of MAP below 65 mmHg during induction [Срок оценки: From start of propofol administration to 10 minutes after endotracheal intubation]
Вторичные конечные точки (12)
  • Incidence of MAP below 65 mmHg [Срок оценки: From start of propofol administration to 10 minutes after endotracheal intubation]
  • Incidence of severe hypotension (MAP below 55 mmHg) [Срок оценки: From start of propofol administration to 10 minutes after endotracheal intubation]
  • Largest decrease in MAP from baseline [Срок оценки: From baseline before study-drug infusion to 10 minutes after endotracheal intubation]
  • Number of Participants Requiring Rescue Vasopressor [Срок оценки: From baseline before study-drug infusion to 10 minutes after endotracheal intubation]
  • Number of Participants With Bradycardia [Срок оценки: From start of propofol administration to 10 minutes after endotracheal intubation]
  • Postoperative lactate concentration [Срок оценки: Preoperative baseline and within 24 hours after surgery]
  • Total Rescue Vasopressor Dose [Срок оценки: From baseline before study-drug infusion to 10 minutes after endotracheal intubation]
  • Number of Participants With Tachycardia [Срок оценки: From start of propofol administration to 10 minutes after endotracheal intubation]
  • Number of Participants Requiring Atropine [Срок оценки: From start of propofol administration to 10 minutes after endotracheal intubation]
  • Number of Participants With Clinically Significant Arrhythmias [Срок оценки: From start of propofol administration to 10 minutes after endotracheal intubation]
  • Number of Participants Admitted to the Intensive Care Unit After Surgery [Срок оценки: From end of surgery to hospital discharge]
  • Number of Participants With Early Postoperative Complications [Срок оценки: From end of surgery to hospital discharge]

Критерии участия

Критерии включения

  • Adults aged 18 years or older.
  • Secondary peritonitis requiring emergency surgery under general anesthesia with endotracheal intubation.
  • Planned induction with fentanyl, propofol, and rocuronium according to the study protocol.
  • Hemodynamically stabilized after initial resuscitation, with MAP at least 65 mmHg and no ongoing vasopressor infusion before induction.
  • ASA physical status I to III.
  • Written informed consent from the participant or a legally authorized representative.

Критерии исключения

  • Allergy or contraindication to norepinephrine, propofol, fentanyl, or rocuronium.
  • Severe cardiovascular disease likely to confound hemodynamic assessment, including decompensated heart failure, acute coronary syndrome, severe arrhythmia, severe valvular disease, or major cardiomyopathy.
  • Ongoing vasopressor therapy before induction.
  • Shock before surgery, including hypovolemic, septic, or cardiogenic shock.
  • Severe hypertension before induction (systolic blood pressure >180 mmHg or mean arterial pressure >110 mmHg).
  • Severe peripheral vascular disease or clinically significant limb ischemia.
  • Current monoamine oxidase inhibitor use.
  • Pregnancy or breastfeeding.
  • Contraindication to arterial catheter placement.
  • Refusal of consent.

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
Четверное слепое
Основная цель
Профилактика

Центры проведения

Вьетнам · 1 центр
  • Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital — Hanoi

Идентификаторы

NCT: NCT07529795 · TTGMHS-NA-PP-2026-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗