Clinical trial NCT06259760: AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury (Nontraumatic)
Hypotension Drug-Induced
Keywords: Acute Kidney Injury
orthognathic surgery
general anesthesia
prospective analysis
intentional hypotension
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected.

Brief summary: 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.

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

Primary outcomes:
measure: urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery.
timeFrame: intraoperative and postoperative stages, assessed up to 24 hours
measure: permitted hypotension during surgery
timeFrame: intraoperative 2-6 hours
measure: consumption of inhaled and intravenous anesthetics
timeFrame: intraoperative 2-6 hours
Secondary outcomes:
measure: time to successfully extubate the nasotracheal tube after anesthesia
timeFrame: from the end of surgery to the post-anesthesia care, assessed up to one hour
measure: safely discharged from post-anesthesia care unit (postoperative recovery room)
timeFrame: 2 hours
measure: side effects and adverse events
timeFrame: intraoperative and postoperative stages, assessed up to 48 hours
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Sanmin Dist
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Kuang-I Cheng, Phd
role: PRINCIPAL_INVESTIGATOR
References: