Controlled Hypotension and Renal Injury During Septoplasty

Fatih Sultan Mehmet Training and Research Hospital110 enrolled

Overview

This prospective randomized single-blind study investigated the effects of two different mean arterial pressure (MAP) targets during controlled hypotension on renal injury in patients undergoing septoplasty. Participants were randomized to a low MAP target group (50-57 mmHg) or a higher MAP target group (58-65 mmHg). Renal injury was assessed using plasma neutrophil gelatinase-associated lipocalin (NGAL) levels measured at baseline, 6 hours, and 24 hours postoperatively.

Controlled hypotension is frequently used during septoplasty to reduce intraoperative bleeding and improve surgical field visibility. However, excessive reductions in mean arterial pressure (MAP) may impair renal perfusion and potentially contribute to postoperative kidney injury. Traditional markers of renal dysfunction, such as serum creatinine, may not detect early renal injury. Neutrophil gelatinase-associated lipocalin (NGAL) has emerged as a sensitive biomarker for the early detection of acute kidney injury. This prospective randomized study was designed to evaluate the effects of two different MAP target ranges during controlled hypotension on renal injury in patients undergoing elective septoplasty under general anesthesia. Patients were randomly assigned to one of two groups: a lower MAP target group (50-57 mmHg) and a higher MAP target group (58-65 mmHg). Controlled hypotension was achieved according to standard anesthetic practice throughout surgery. Renal injury was assessed by measuring plasma NGAL concentrations preoperatively and at predetermined postoperative time points. Additional renal function parameters, including serum creatinine levels, urine output, and acute kidney injury classifications, were evaluated. Intraoperative hemodynamic variables and renal regional oxygen saturation values were also recorded. The primary objective of the study was to determine whether different levels of controlled hypotension influence early renal injury as assessed by NGAL measurements. Secondary objectives included evaluation of conventional renal function parameters, renal tissue oxygenation, and perioperative hemodynamic outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

Conditions

Hypotension During Surgery NGAL Kidney Injury

Interventions

Controlled Hypotension (MAP 50-57 mmHg)PROCEDURE

Controlled hypotension was maintained intraoperatively with a target MAP range of 50-57 mmHg according to the study protocol.

Controlled Hypotension (MAP 58-65 mmHg)PROCEDURE

Controlled hypotension was maintained intraoperatively with a target MAP range of 58-65 mmHg according to the study protocol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18 to 65 years * Scheduled for elective septoplasty under general anesthesia * American Society of Anesthesiologists (ASA) physical status I-II * Planned controlled hypotension during surgery * Provided written informed consent Exclusion Criteria: * Body mass index (BMI) \> 35 kg/m² * History of hypertension * Diabetes mellitus * Coronary artery disease * Cerebrovascular disease * Carotid artery stenosis * Vertebrobasilar insufficiency * Pre-existing renal dysfunction * Anemia * Hypovolemia * Refusal to participate in the study

Locations (1)

FSMTRH

Istanbul, Ataşehir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration

Plasma NGAL concentrations were measured to assess early renal injury associated with different target mean arterial pressure ranges during controlled hypotension.

Time frame: After anesthesia induction as a baseline, 6 hours and 24 hours post-induction

Secondary Outcomes

Serum Creatinine Concentration

Serum Creatinine levels were measured to evaluate postoperatinve renal function.

Time frame: After anesthesia induction as a baseline, 6 hours and 24 hours post-induction

Acute Kidney Injury Network (AKIN) Classification

AKIN scores were determined using serum creatinine measurements and calculated urine output values obtained during the first 24 postoperative hours.

Time frame: After anesthesia induction 6,12 and 24th hours

Urine Output

Urine volumes were collected in separate containers during the first 6 hours, the second 6 hours, and the subsequent 12 hours following anesthesia induction. Hourly urine output per kilogram body weight was calculated for the 0-6, 0-12, and 0-24 hour periods.

Time frame: 0-6 hours, 6-12 hours, and 12-24 hours after anesthesia induction

Renal Regional Oxygen Saturation (rSO₂)

Renal regional oxygen saturation (rSO₂) was measured using near-infrared spectroscopy (NIRS) to evaluate the effects of different controlled hypotension targets on renal tissue oxygenation during septoplasty.

Time frame: Throughout surgery and at predefined intraoperative measurement time points

Data from ClinicalTrials.gov

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