Clinical trial

Effect of Obesity Phenotype on Intraabdominal Pressure and Bleeding in Major Lumbar Spinal Surgery

Opening soon · Not applicable · 0 countries · Registry ID NCT07688265

Opening soonNot applicableObservational

What this study is about

Obesity is prevalent among patients with lumbar degenerative disease and is a known risk factor for perioperative complications in spinal surgery. However, most existing evidence relies solely on body mass index (BMI) without distinguishing between central and peripheral obesity phenotypes. Central and peripheral fat distribution may have distinct biomechanical and hemodynamic consequences, particularly with respect to intraabdominal pressure (IAP) changes during prone positioning and intraoperative blood loss. This prospective single-center observational study aims to evaluate the effect of obesity phenotype - classified as non-obese, centrally obese, or peripherally obese based on BMI and waist-to-hip ratio - on intraabdominal pressure, intraoperative blood loss, and other perioperative outcomes in adult patients undergoing major lumbar spinal surgery (decompression and/or instrumentation)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionLumbar Spinal Stenosis, Lumbar Degenerative Disease, Obesity, Intraabdominal Hypertension, Intraoperative Blood Loss, Perioperative Complications

Full registry criteria

Inclusion Criteria: * Age 18-80 years * ASA Physical Status Classification I-III * Scheduled for elective major lumbar spinal surgery (canal stenosis decompression and/or instrumented fusion) * No prior lumbar spinal surgery * Written informed consent obtained Exclusion Criteria: * \- Pediatric patients (\<18 years) * Pregnancy * Emergency surgical procedures * Pre-existing renal failure * Coagulation disorder * Pre-existing anemia * Known drug allergy relevant to study medications * Inability to obtain written informed consent

Treatments and study arms

Intraabdominal Pressure Measurement via Urinary Bladder Catheter

Other

Intravesical intraabdominal pressure measurement performed via indwelling urinary catheter at three standardized time points: supine position after intubation, prone position during surgery, and supine position at end of surgery. This measurement is performed as part of observational data collection within the scope of routine catheterization; no additional invasive procedure is applied.

Total Intravenous Anesthesia (TIVA)

Other

Standardized TIVA protocol applied uniformly to all patients per institutional neuromonitoring-guided spinal surgery protocol. Induction with propofol 2 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg; maintenance with propofol and remifentanil infusion. Adjusted body weight used for drug dosing in obese patients. No study-specific modification to routine anesthetic management is performed. Arm Label: All Groups (NO, PO, CO)

Primary outcomes

Intraoperative Blood LossIntraoperative

Total estimated blood loss (mL) calculated from suction canister volume and surgical sponge weight.

Intraabdominal Pressure (IAP)Three intraoperative time points from beginning to end: 1.supine after intubation, 2.prone position, and 3.supine at end of surgery

Intravesical IAP measurement (mmHg) via urinary bladder catheter at positional transitions during surgery

Study locations

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No public site location was included in this record. Check the original registry for updates.