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Controlled Hypotension and Renal Injury During Septoplasty

Effects of Two Different Mean Arterial Pressure Targets During Controlled Hypotension on Renal Injury Assessed by NGAL Levels in Patients Undergoing Septoplasty

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07662577
Enrollment
110
Registered
2026-06-23
Start date
2019-05-01
Completion date
2020-08-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension During Surgery, Kidney Injury, NGAL

Keywords

NGAL, Kidney Injury, Hypotension, NIRS

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREControlled Hypotension (MAP 50-57 mmHg)

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

PROCEDUREControlled Hypotension (MAP 58-65 mmHg)

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

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

Participants were randomized to one of two parallel groups receiving controlled hypotension with different target MAP ranges (50-57 mmHg or 58-65 mmHg) during septoplasty.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentrationAfter anesthesia induction as a baseline, 6 hours and 24 hours post-inductionPlasma NGAL concentrations were measured to assess early renal injury associated with different target mean arterial pressure ranges during controlled hypotension.

Secondary

MeasureTime frameDescription
Serum Creatinine ConcentrationAfter anesthesia induction as a baseline, 6 hours and 24 hours post-inductionSerum Creatinine levels were measured to evaluate postoperatinve renal function.
Acute Kidney Injury Network (AKIN) ClassificationAfter anesthesia induction 6,12 and 24th hoursAKIN scores were determined using serum creatinine measurements and calculated urine output values obtained during the first 24 postoperative hours.
Urine Output0-6 hours, 6-12 hours, and 12-24 hours after anesthesia inductionUrine 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.
Renal Regional Oxygen Saturation (rSO₂)Throughout surgery and at predefined intraoperative measurement time pointsRenal 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026