Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery

Обзор

It is known that more or less pronounced impairment of pulmonary function occurs after anesthesia. It has been demonstrated in the postoperative period in both patients undergoing general and regional anesthesia, in patients after intra-abdominal and superficial procedures, in overweight and normal-weight patients. It has also been shown that when general anesthesia is performed with the inhalation anesthetic sevoflurane, there is a slightly smaller reduction in lung function parameters than when only intravenous anesthetics are used. The purpose of this study is to evaluate lung function before induction and after awakening from general anesthesia depending on the inhalational anesthetic used in obese patients undergoing bariatric surgery

Вмешательства

• Препарат Different drug type for conduction of general anesthesia
  Patients will be randomly divided into two groups: patients for whom general anesthesia will be performed with sevoflurane and patients for whom general anesthesia will be performed with desflurane.

Первичные конечные точки

• Heart rate (HR) [Срок оценки: Continuously during whole duration of anesthesia]
• Pulse oximetry (SpO2) [Срок оценки: Continuously during whole duration of anesthesia]
• End tidal CO2 (etCO2) [Срок оценки: Continuously during whole duration of anesthesia]
• Minimum alveolar concentration (MAC) [Срок оценки: Continuously during whole duration of anesthesia]
• Bispectral index (BIS) [Срок оценки: Continuously during whole duration of anesthesia]
• Train of for (TOF) [Срок оценки: Every 2.5 minutes during whole duration of anesthesia]
• Non invasive blood pressure (NIBP) [Срок оценки: Every 5 minutes during whole duration of anesthesia]
• Forced vital capacity (FVC) [Срок оценки: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia]
• Volume that has been exhaled at the end of the first second of forced expiration (FEV1) [Срок оценки: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia]
• Mid-expiratory flow; the rates at 25% FVC (MEF25) [Срок оценки: 3 months before the surgery and 10 and 30 minutes after the emergence from general anesthesia]

Критерии участия

Критерии включения

• Obese patients qualified for bariatric surgery.

Критерии исключения

• Patients who have absolute contraindications to spirometry testing, i.e:

• with aneurysms of the aorta or cerebral arteries threatening to rupture, after recent vascular surgery
• with increased intracranial pressure, after recent intracranial bleeding or head surgery within the cranial cavity
• after acute conditions within 6 months prior to surgery such as stroke, myocardial infarction, unstable angina, pneumothorax
• with uncontrolled hypertension
• after recent eye surgery or a history of retinal detachment
• with hemoptysis of unknown etiology. And patients unable to perform spirometry testing

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

Открытое

Основная цель

Другое

Центры проведения

Польша · 1 центр

• University Clinical Center — Gdansk

Идентификаторы

NCT: NCT06759623 · KO_bariatria

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗