TCI Versus Manual TIVA for Sedation During Prone Kyphoplasty: Effects on Respiration, Recovery, and EEG

Официальное название

Investigation of the Effects of Target-Controlled Infusion (TCI) Anesthesia on Respiration, Recovery, and Electroencephalogram in Patients Undergoing Kyphoplasty in the Prone Position

Обзор

This single-center, prospective, observational study compares target-controlled infusion (TCI) versus manually administered total intravenous anesthesia (TIVA) for sedation in patients undergoing kyphoplasty in the prone position. The primary endpoints are the incidence of hypoxic episodes (SpO₂ \< 90%) and apneic attacks. Secondary endpoints include anesthesia quality scores, integrated pulmonary index (IPI) values, total propofol consumption, time to eye opening, time to full orientation, Modified Aldrete Scores and Richmond Agitation-Sedation Scale (RASS) scores in the recovery unit, and patient and surgeon satisfaction.

Подробное описание

Kyphoplasty is a minimally invasive spinal procedure commonly performed for osteoporotic vertebral compression fractures. The procedure involves balloon elevation of the collapsed vertebral body followed by injection of polymethylmethacrylate (PMMA) bone cement for stabilization. The procedure is performed in the prone position and typically involves 1-2 vertebral levels.

Total intravenous anesthesia (TIVA), using combinations of propofol and remifentanil, is an alternative to inhalation anesthesia. TIVA can be administered manually or via target-controlled infusion (TCI) systems. TCI systems use pharmacokinetic models to achieve and maintain targeted plasma or effect-site concentrations. Studies in endoscopy settings have demonstrated that TCI-based sedation provides more stable sedation depth, fewer hemodynamic fluctuations, and faster recovery compared to manual administration.

Kyphoplasty procedures are typically performed in elderly patients with multiple comorbidities in the prone position under fluoroscopic guidance. The prone position, while mandatory for kyphoplasty, presents significant anesthesia management challenges: limited airway access increases the risk of respiratory depression during sedation, and chest compression impairs ventilation mechanics and may reduce alveolar ventilation. Therefore, meticulous respiratory monitoring during kyphoplasty is essential.

The Capnostream® device records four variables (SpO₂, respiratory rate, non-invasive EtCO₂, and heart rate) every 30 seconds via a nasal cannula and integrates them into a single unitless value called the Integrated Pulmonary Index (IPI), ranging from 1 to 10. An IPI of 4 or below requires intervention, while 8-10 represents the normal range. Additionally, bispectral index (BIS) monitoring enables objective tracking of anesthesia depth through EEG waveform analysis.

This study aims to compare manual TIVA versus TCI methods regarding sedation depth, respiratory stability, hemodynamic parameters, and recovery in patients undergoing kyphoplasty in the prone position. The findings are expected to contribute to determining the optimal anesthesia approach in this patient population.

Вмешательства

• Процедура Target controlled infusion of propofol
  In patients in group TCI, target-controlled propofol sedation will be administered using an elevated (opioid) model, and the target concentration will be titrated between 1-2 mcg/ml.
• Устройство non invasive ETCO2 monitoring
  The Capnostream® device records four variables (SpO₂, respiratory rate, non-invasive EtCO₂, and heart rate) every 30 seconds via a nasal cannula and integrates them into a single unitless value called the Integrated Pulmonary Index (IPI), ranging from 1 to 10. An IPI of 4 or below requires intervention, while 8-10 represents the normal range

Первичные конечные точки

• . Number of Hypoxic Episodes [Срок оценки: from sedation initiation to end of procedure,Intraoperatively]

Вторичные конечные точки (5)

• Anesthesia Quality Score (0-32) [Срок оценки: from sedation initiation to end of procedure, Intraoperatively.]
• Integrated Pulmonary Index (IPI) Values [Срок оценки: Every 10 minutes intraoperatively, during sedation procedures]
• Total Propofol Consumption [Срок оценки: Intraoperatively, from sedation initiation to end of procedure]
• Time to Eye Opening [Срок оценки: From end of procedure to first eye opening, up to 10 minutes]
• Surgeon Satisfaction [Срок оценки: end of the procedure.]

Критерии участия

Критерии включения

\- Age 18 years and older

• ASA physical status classification I-III
• Scheduled for kyphoplasty under sedation in the prone position
• Provision of written informed consent

Критерии исключения

• Known allergy to any of the study medications

• ASA physical status classification IV or higher
• Patients deemed unsuitable for sedation (high pulmonary risk, morbid obesity, diagnosed severe obstructive sleep apnea)
• Refusal to participate or withdrawal of consent
• Diagnosis of dementia or Alzheimer's disease
• Communication difficulties precluding adequate assessment

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Seniyye Ülgen Zengin — Istanbul

Публикации

• Ding Y, White PF. Simplified quality of anaesthesia scoring system. Anaesthesia. 1992 Oct;47(10):906-7. doi: 10.1111/j.1365-2044.1992.tb03166.x. No abstract available. PMID 1294143
• Sandler NA, Hodges J, Sabino M. Assessment of recovery in patients undergoing intravenous conscious sedation using bispectral analysis. J Oral Maxillofac Surg. 2001 Jun;59(6):603-11; discussion 611-2. doi: 10.1053/joms.2001.23366. PMID 11381378
• Chang YT, Tsai TC, Hsu H, Chen YM, Chi KP, Peng SY. Sedation for gastrointestinal endoscopy with the application of target-controlled infusion. Turk J Gastroenterol. 2015 Sep;26(5):417-22. doi: 10.5152/tjg.2015.0206. PMID 26350688

Идентификаторы

NCT: NCT07745348 · MJR KYPHO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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