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AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06259760
Enrollment
50
Registered
2024-02-14
Start date
2024-03-01
Completion date
2026-12-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury (Nontraumatic), Hypotension Drug-Induced

Keywords

Acute Kidney Injury, orthognathic surgery, general anesthesia, prospective analysis, intentional hypotension

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.

Interventions

DRUGNitroglycerin

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.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery.intraoperative and postoperative stages, assessed up to 24 hoursRecord blood and urine biomarkers, and urine output after operation
permitted hypotension during surgeryintraoperative 2-6 hoursassess 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
consumption of inhaled and intravenous anestheticsintraoperative 2-6 hoursto maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated

Secondary

MeasureTime frameDescription
time to successfully extubate the nasotracheal tube after anesthesiafrom the end of surgery to the post-anesthesia care, assessed up to one hourearly extubation allowable
safely discharged from post-anesthesia care unit (postoperative recovery room)2 hoursas calculating the time from patient is delivered to postoperative recovery room to be safely discharged from recovery room by using the aldrete scores (activities level, respiration, circulation, conscious level, oxygenation) full back to pre-operative level or ten scores.
side effects and adverse eventsintraoperative and postoperative stages, assessed up to 48 hoursrecords any abnormal surgical or anesthesia related findings during this admission

Countries

Taiwan

Contacts

Primary ContactKuang-I Cheng, Phd
kuaich@gmail.com886-7-3121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026