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Набор скоро начнётся NCT07378605

Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery

Без фазы С лечением Bariatric Surgery

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: Salbutamol (Ventolin®), Normal Saline (0.9% Sodium Chloride).
Кому может быть актуально
Состояния в реестре: Bariatric Surgery. Базовые параметры: 18 лет — 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
Turkey (Türkiye)
Следующий шаг
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Обзор

The primary objective of this study is to evaluate the effect of intraoperative salbutamol administration on mechanical power in obese patients undergoing laparoscopic bariatric surgery under general anesthesia. Mechanical power will be measured at predefined intraoperative time points (T0, T1, and T2), and changes over time will be compared to determine the impact of salbutamol on the overall energy delivered to the respiratory system during mechanical ventilation. Secondary objectives include the assessment of intraoperative respiratory mechanics, including peak airway pressure (Ppeak), plateau pressure (Pplat), driving pressure (Pdrive), airway resistance (Raw), and lung compliance, as well as gas exchange parameters (SpO₂, EtCO₂) and hemodynamic variables (mean arterial pressure). Postoperative pulmonary outcomes will be evaluated using the Melbourne Group Scale (MGS), with a score greater than 4 indicating the presence of postoperative pulmonary complications. The study aims to investigate whether improvement in intraoperative mechanical power and respiratory mechanics is associated with a reduction in postoperative pulmonary complications in this high-risk population.

Вмешательства

  • Препарат Salbutamol (Ventolin®)
    Salbutamol will be administered intraoperatively via the respiratory circuit during mechanical ventilation to assess its effect on mechanical power and respiratory mechanics.
  • Препарат Normal Saline (0.9% Sodium Chloride)
    Normal saline will be administered intraoperatively via the respiratory circuit in the same volume and manner as salbutamol to serve as a placebo

Первичные конечные точки

  • Change in intraoperative mechanical power [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
Вторичные конечные точки (9)
  • Peak airway pressure (Ppeak) [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Plateau pressure (Pplat) [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Driving pressure (Pdrive) [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Airway resistance (Raw) [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Lung compliance [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Lung elastance (E) [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Heart rate (HR / Nabız) [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Mean arterial pressure (MAP) [Срок оценки: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
  • Postoperative pulmonary complications (Melbourne Group Scale >4) [Срок оценки: First assessment: Within 24 hours postoperatively Second assessment: 48 hours postoperatively Third assessment: Immediately before hospital discharge]

Критерии участия

Критерии включения

  • Age: 18-65 years

BMI ≥35 kg/m² (candidates for obesity surgery)

Scheduled for elective laparoscopic bariatric surgery

ASA physical status I-III

Signed informed consent

Критерии исключения

Known allergy or contraindication to salbutamol

Severe cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia)

Pre-existing severe pulmonary disease (e.g., severe COPD, asthma exacerbation)

Pregnancy or lactation

Emergency surgery

Use of β-agonists or bronchodilators within 24 hours prior to surgery

Patients with inability to provide informed consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр
  • Health Sciences University Gazi Yaşargil Training and Research Hospital — Kayapınar

Идентификаторы

NCT: NCT07378605 · Hts

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗