AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery
unlimited mouth opening
Disqualifiers
patients with arthritis with limited mouth opening
persistent liver dysfunction
chronic renal insufficiency
body mass index ≧35 kg/m2.
Trial population
Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Nitroglycerin
Drugduring 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery.
Record blood and urine biomarkers, and urine output after operation
Time frame
intraoperative and postoperative stages, assessed up to 24 hours2
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
Time frame
intraoperative 2-6 hours3
consumption of inhaled and intravenous anesthetics
to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated
Time frame
intraoperative 2-6 hoursSecondary outcomes
1
time to successfully extubate the nasotracheal tube after anesthesia
early extubation allowable
Time frame
from the end of surgery to the post-anesthesia care, assessed up to one hour2
safely discharged from post-anesthesia care unit (postoperative recovery room)
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.
Time frame
2 hours3
side effects and adverse events
records any abnormal surgical or anesthesia related findings during this admission
Time frame
intraoperative and postoperative stages, assessed up to 48 hoursSponsors and contacts
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Source ClinicalTrials.gov