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Набор скоро начнётся NCT07688265

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

Наблюдательное Lumbar Spinal Stenosis Lumbar Degenerative Disease Obesity Intraabdominal Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intraabdominal Pressure Measurement via Urinary Bladder Catheter, Total Intravenous Anesthesia (TIVA).
Кому может быть актуально
Состояния в реестре: Lumbar Spinal Stenosis, Lumbar Degenerative Disease, Obesity, Intraabdominal Hypertension. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Obesity Phenotype on Intraabdominal Pressure, Intraoperative Bleeding, and Perioperative Complications in Patients Undergoing Major Lumbar Spinal Surgery: A Prospective Observational Study

Обзор

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)

Подробное описание

Major lumbar spinal surgery, including lumbar canal stenosis decompression and instrumented fusion, is associated with substantial intraoperative blood loss and notable perioperative morbidity. Obesity is highly prevalent in this patient population due to its role in lumbar degenerative disease pathogenesis. Prone positioning during surgery significantly increases intraabdominal pressure, which in turn may impair venous drainage from the spinal epidural plexus, thereby augmenting operative blood loss. While BMI has been studied as a predictor of spinal surgical outcomes, the differential impact of fat distribution pattern (central vs. peripheral obesity) on IAP dynamics and bleeding has not been adequately characterized.

Study Design:

Prospective, single-center, observational cohort study conducted at Marmara University Pendik Training and Research Hospital and Asaf Ataseven Hospital, Istanbul, Turkey. No interventions beyond routine clinical anesthesia practice will be performed.

Patient Groups:

Patients will be categorized into three groups based on BMI and waist-to-hip ratio (WHR):

* Group NO (Non-obese): BMI \<30 kg/m² (n=30) * Group PO (Peripheral obese): BMI ≥30 kg/m² and WHR \<0.85 (n=30) * Group CO (Central obese): BMI ≥30 kg/m² and WHR ≥0.85 (n=30)

Anesthetic Protocol:

All patients will receive standard intraoperative monitoring (ECG, non-invasive blood pressure, pulse oximetry, end-tidal CO₂, BIS). Anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg, and maintained with total intravenous anesthesia (TIVA) using propofol and remifentanil infusion, consistent with the institutional protocol for neuromonitoring-guided spinal surgery. Adjusted body weight will be used for drug dosing in obese patients.

Intraabdominal Pressure Measurement:

IAP will be measured via urinary bladder catheter (standard intravesical technique) at three time points: (1) supine position after intubation, (2) prone position, and (3) supine position at the end of surgery.

Data Collection:

Preoperative: age, sex, BMI, weight, height, waist and hip circumferences, WHR, ASA classification, comorbidities, baseline hemogram, BUN, creatinine, INR, aPTT, anticoagulant/antiplatelet use.

Intraoperative: surgical procedure type and level, revision status, anesthesia and surgery duration, neuromonitoring use, hemodynamic parameters at standardized time points, estimated blood loss, fluid and blood product administration, vasopressor/inotrope use, urine output, cell saver use.

Postoperative: hemoglobin and hematocrit drop, BUN, creatinine at 24 hours, Aldrete score, VAS score, ICU admission and indication, postoperative complications (surgical and medical), transfusion requirements, and total hospital length of stay.

Statistical Analysis:

SPSS 21.0 will be used. Continuous variables will be reported as mean ± SD or median (IQR) depending on normality (Kolmogorov-Smirnov/Shapiro-Wilk). Categorical variables will be reported as n (%). Between-group comparisons will employ one-way ANOVA or Kruskal-Wallis test for continuous variables and chi-square or Fisher's exact test for categorical variables. Post-hoc pairwise comparisons will be performed with appropriate correction. Significance threshold: p\<0.05.

Sample Size:

Based on published BMI-stratified spinal surgery data, a minimum of 90 patients (30 per group) is required to achieve 80% power at α=0.05 (G\*Power 3.1).

Вмешательства

  • Другое Intraabdominal Pressure Measurement via Urinary Bladder Catheter
    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.
  • Другое Total Intravenous Anesthesia (TIVA)
    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)

Первичные конечные точки

  • Intraoperative Blood Loss [Срок оценки: Intraoperative]
  • Intraabdominal Pressure (IAP) [Срок оценки: Three intraoperative time points from beginning to end: 1.supine after intubation, 2.prone position, and 3.supine at end of surgery]
Вторичные конечные точки (9)
  • Intraoperative Transfusion Requirement [Срок оценки: Intraoperative]
  • Postoperative Hemoglobin Drop [Срок оценки: Within 24 hours postoperatively]
  • Vasopressor/Inotrope Requirement [Срок оценки: Intraoperative]
  • Postoperative Transfusion Requirement [Срок оценки: up to 7 days postoperatively]
  • Postoperative ICU Admission Rate [Срок оценки: postoperative day 1]
  • Postoperative Surgical Complications [Срок оценки: Up to 30 days postoperatively]
  • Postoperative Medical Complications [Срок оценки: Up to 30 days postoperatively]
  • Hospital Length of Stay [Срок оценки: From surgery to hospital discharge, assessed up to 30 days]
  • Acute Kidney Injury Incidence [Срок оценки: Time Frame: Within 24 hours postoperatively]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • \- 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07688265 · mu anesth

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗