Actively Recruiting
Incidence and Risk Factors Analysis of Acute Kidney Injury After Intentional Hypotensive Anesthesia in Orthognathic Surgery Patients Following Enhanced Recovery After Surgery Guidelines
Led by Kaohsiung Medical University Chung-Ho Memorial Hospital · Updated on 2024-02-14
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of intentionally lowering blood pressure during general anesthesia in patients undergoing orthognathic surgery. This study aims to assess the potential risk of acute kidney injury (AKI) by monitoring kidney function indicators such as serum creatinine and urine analysis throughout the surgery. The goal is to identify early risk factors for AKI to help prevent postoperative kidney damage and support faster recovery following Enhanced Recovery After Surgery (ERAS) guidelines. Participants receive either nitroglycerin alone or nitroglycerin combined with labetalol to lower blood pressure during the operation. Throughout the surgery, their arterial blood pressure and other vital signs like cardiac output and oxygen levels are continuously monitored. The study observes these parameters during the 2 to 6 hours of surgery and tracks anesthesia drug usage. Postoperative monitoring includes the time to remove breathing tubes, discharge from recovery, and any side effects or adverse events for up to 48 hours. During the study, participants will have urine and blood tests to measure kidney function before, during, and up to 24 hours after surgery. Researchers will also track vital signs and anesthesia details closely during and after the operation. This detailed monitoring helps evaluate kidney health and overall recovery, with safety assessments continuing for two days post-surgery. The total participation duration covers the surgical period and the immediate postoperative recovery phase.
CONDITIONS
Brief Title
AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery
- Unlimited mouth opening
- Age between 18 and 65 years
You will not qualify if you...
- Patients with arthritis with limited mouth opening
- Persistent liver dysfunction
- Chronic renal insufficiency
- Body mass index 63;35 kg/m2
- Past history of malignant hyperthermia or personal or family history
- Diabetes with insulin treatment
- Essential hypertension without controlled
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 6 hours
Participants undergo orthognathic surgery during which blood pressure is intentionally lowered using nitroglycerin infusion or nitroglycerin with labetalol to reduce blood loss. Continuous monitoring of arterial blood pressure and other hemodynamic parameters is performed during surgery.
1 intraoperative visit
Duration - Up to 48 hours
After surgery, participants are monitored for kidney function using urine biomarkers, urine output, and blood creatinine, as well as for anesthesia recovery, side effects, and adverse events.
Approximately 2 to 3 visits including post-anesthesia care unit stay and follow-up assessments
Trial Site Locations
Total: 1 location
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, Taiwan, 80756
Actively Recruiting
Research Team
K
Kuang-I Cheng, Phd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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