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临床试验/NCT06259760
NCT06259760招募中不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
consumption of inhaled and intravenous anesthetics

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

consumption of inhaled and intravenous anesthetics

时间窗: intraoperative 2-6 hours

to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated

urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery.

时间窗: intraoperative and postoperative stages, assessed up to 24 hours

Record blood and urine biomarkers, and urine output after operation

permitted hypotension during surgery

时间窗: intraoperative 2-6 hours

assess intraoperative blood loss and the dosage of hypotensive medications to decrease intra-operative bleeding as patient undergoing oromaxillofacial surgery, intentional hypotension is allowed. however, adequate depth of anesthesia, proper cardiac output, respiratory parameters, temperatures should be monitored

次要结局

  • safely discharged from post-anesthesia care unit (postoperative recovery room)(2 hours)
  • side effects and adverse events(intraoperative and postoperative stages, assessed up to 48 hours)
  • time to successfully extubate the nasotracheal tube after anesthesia(from the end of surgery to the post-anesthesia care, assessed up to one hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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