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Идёт набор NCT06259760

AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

— Наблюдательное Acute Kidney Injury (Nontraumatic) Hypotension Drug-Induced

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: Nitroglycerin.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury (Nontraumatic), Hypotension Drug-Induced. 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
Тайвань
Следующий шаг
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Официальное название

Incidence and Risk Factors Analysis of Acute Kidney Injury (AKI) After Intentional Hypotensive Anesthesia in Orthognathic Surgery Patients Following Enhanced Recovery After Surgery (ERAS) Guidelines

Обзор

This project investigates intentionally hypotensive management such as NTG (nitroglycerin) or NTG+Trandate during general anesthesia in patients undergoing orthognathic surgery. Throughout the entire surgical procedure, blood biochemical and urine monitoring will be conducted. Serum creatinine (Cr) levels, urine analysis, and perioperative monitoring will be utilized as indicators for assessing renal function during the surgery. The objective is to assess its potential renal injury and identify early risk factors for acute kidney injury (AKI). Timely recognition of these factors will allow for the implementation of appropriate intervention strategies, aiding in the prevention of postoperative acute kidney injury. This approach contributes to achieving the goals of Enhanced Recovery After Surgery (ERAS) for surgical patients, promoting faster postoperative recovery.

Подробное описание

Orthognathic surgery is currently a common procedure in oral and maxillofacial surgery. The facial region is composed of a complex and dense vascular network, requiring precise, accurate, and delicate surgical techniques on both hard and soft tissues. During intraoral procedures, the surgical field may be limited, making the management of surgical bleeding challenging. Controlled hypotension or hypotensive anesthesia is often employed during major maxillofacial surgeries to optimize conditions. Lowering blood pressure is advantageous as it helps reduce overall blood loss and improves the surgeon's visibility. Therefore, maintaining stable blood pressure within the ideal range during the surgical process is a critical anesthesia objective.

This research emphasizes the prevention of acute kidney injury (AKI) in patients undergoing orthognathic surgery with intentional hypotension during general anesthesia. The goal is to detect the potential renal damage at an early stages, before a significant decline in kidney function occurs, thereby reducing the likelihood of acute kidney injury.

Вмешательства

  • Препарат Nitroglycerin
    during surgery, the patient received nitroglycerin infusion or nitroglycerin with labetalol to decrease blood pressure and to decrease blood loss. During the procedures and management, patients were executed of continuously monitoring of arterial blood pressure, hemodynamic changes such as cardiac output, stroke volume variation, peripheral oxygen saturation, and cerebral oximeter.

Первичные конечные точки

  • urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery. [Срок оценки: intraoperative and postoperative stages, assessed up to 24 hours]
  • permitted hypotension during surgery [Срок оценки: intraoperative 2-6 hours]
  • consumption of inhaled and intravenous anesthetics [Срок оценки: intraoperative 2-6 hours]
Вторичные конечные точки (3)
  • time to successfully extubate the nasotracheal tube after anesthesia [Срок оценки: from the end of surgery to the post-anesthesia care, assessed up to one hour]
  • safely discharged from post-anesthesia care unit (postoperative recovery room) [Срок оценки: 2 hours]
  • side effects and adverse events [Срок оценки: intraoperative and postoperative stages, assessed up to 48 hours]

Критерии участия

Критерии включения

  • America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery
  • unlimited mouth opening

Критерии исключения

  • patients with arthritis with limited mouth opening
  • persistent liver dysfunction
  • chronic renal insufficiency
  • body mass index ≧35 kg/m2.
  • past history of malignant hyperthermia or personal or family history
  • diabetes with insulin treatment
  • essential hypertension without controlled

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Тайвань · 1 центр
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Идентификаторы

NCT: NCT06259760 · KMUHIRB-E(I)-20240015

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗