AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

NCT06259760 | Recruiting DMC

• 1 other identifier: KMUHIRB-E(I)-20240015
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury (Nontraumatic); Hypotension Drug-Induced

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  Record blood and urine biomarkers, and urine output after operation

  intraoperative and postoperative stages, assessed up to 24 hours

• permitted hypotension during surgery

  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

• consumption of inhaled and intravenous anesthetics

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

  intraoperative 2-6 hours

Secondary Outcomes (3)

• time to successfully extubate the nasotracheal tube after anesthesia

  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)

  2 hours

• side effects and adverse events

  intraoperative and postoperative stages, assessed up to 48 hours

Interventions

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.

Also known as: labetalol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery
• unlimited mouth opening

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 80756, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Hypotension

Interventions

Nitroglycerin; Labetalol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides; Amides; Amines

Study Officials

• Kuang-I Cheng, Phd

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-I Cheng, Phd

CONTACT

886-7-3121101; kuaich@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 14, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-01

Locations

TW (1)