AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nitroglycerin.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury (Nontraumatic), Hypotension Drug-Induced. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug 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.
Primary outcome measures
- urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery. [Time frame: intraoperative and postoperative stages, assessed up to 24 hours]
- permitted hypotension during surgery [Time frame: intraoperative 2-6 hours]
- consumption of inhaled and intravenous anesthetics [Time frame: intraoperative 2-6 hours]
Secondary outcome measures (3)
- time to successfully extubate the nasotracheal tube after anesthesia [Time frame: 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) [Time frame: 2 hours]
- side effects and adverse events [Time frame: intraoperative and postoperative stages, assessed up to 48 hours]
Eligibility criteria
Inclusion criteria
- America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery
- unlimited mouth opening
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Taiwan · 1 center
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
Identifiers
NCT: NCT06259760 · KMUHIRB-E(I)-20240015