AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

February 7, 2024 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kuang-I Cheng, PhD
  • Phone Number: 7035 886-7-3121101
  • Email: kuaich@gmail.com

Study Locations

  • Taiwan
    • Sanmin Dist
      • Kaohsiung, Sanmin Dist, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative 2-6 hours
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
intraoperative and postoperative stages, assessed up to 24 hours
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
intraoperative 2-6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the end of surgery to the post-anesthesia care, assessed up to one hour
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.
2 hours
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
intraoperative and postoperative stages, assessed up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Kuang-I Cheng, Phd, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Estimated)

February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-E(I)-20240015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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