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NCT Number: NCT06259760

AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

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.

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Key information

Conditions

Acute Kidney Injury (Nontraumatic) Acute Kidney Injury Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypotension Hypotension Drug-Induced Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 80756, Taiwan

Location status: Recruiting

Location contact

Kuang-I Cheng, Phd

CONTACT

[email protected]

886-7-3121101 ext. 7035

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitroglycerin

Drug

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.

Other names: labetalol

Primary outcomes

  1. urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery.

    Time frame: intraoperative and postoperative stages, assessed up to 24 hours

    Record blood and urine biomarkers, and urine output after operation

  2. permitted hypotension during surgery

    Time frame: intraoperative 2-6 hours

    assess 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

  3. consumption of inhaled and intravenous anesthetics

    Time frame: intraoperative 2-6 hours

    to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated

Secondary outcomes

  1. 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

    early extubation allowable

  2. safely discharged from post-anesthesia care unit (postoperative recovery room)

    Time frame: 2 hours

    as 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.

  3. side effects and adverse events

    Time frame: intraoperative and postoperative stages, assessed up to 48 hours

    records any abnormal surgical or anesthesia related findings during this admission

Study contacts

Contact information is provided by the study sponsor or research team.

Kuang-I Cheng, Phd

CONTACT

[email protected]

886-7-3121101 ext. 7035

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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