AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

NCT ID: NCT06259760

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury (Nontraumatic) Hypotension Drug-Induced

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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labetalol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuang-I Cheng, Phd

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuang-I Cheng, Phd

Role: CONTACT

886-7-3121101 ext. 7035

Facility Contacts

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Kuang-I Cheng, Phd

Role: primary

886-7-3121101 ext. 7035

Other Identifiers

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KMUHIRB-E(I)-20240015

Identifier Type: -

Identifier Source: org_study_id

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