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NCT Number: NCT07745348

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Target controlled infusion of propofol

Procedure

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.

non invasive ETCO2 monitoring

Device

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

Primary outcomes

  1. . Number of Hypoxic Episodes

    Time frame: from sedation initiation to end of procedure,Intraoperatively

    Total number of episodes in which peripheral oxygen saturation drops below 90% during the procedure.(SpO₂ < 90%)

Secondary outcomes

  1. Anesthesia Quality Score (0-32)

    Time frame: from sedation initiation to end of procedure, Intraoperatively.

    Assessed using the Simplified Quality of Anesthesia Scoring System (Ding & White), evaluating motor response, hemodynamic stability, and respiratory stability.

  2. Integrated Pulmonary Index (IPI) Values

    Time frame: Every 10 minutes intraoperatively, during sedation procedures

    Composite index (1-10) integrating SpO₂, respiratory rate, EtCO₂, and heart rate measured via Capnostream® device.

  3. Total Propofol Consumption

    Time frame: Intraoperatively, from sedation initiation to end of procedure

    Total amount of propofol administered during the procedure (mg).

  4. Time to Eye Opening

    Time frame: From end of procedure to first eye opening, up to 10 minutes

    Time in minutes from end of the procedure to spontaneous eye opening.

  5. Surgeon Satisfaction

    Time frame: end of the procedure.

    Assessed on a 4-point scale: very good, good, fair, poor.

Study contacts

Contact information is provided by the study sponsor or research team.

dilara göçmen, asst prof

CONTACT

[email protected]

+90 5413439438

Sponsors and collaborators

Lead sponsor

Marmara University Pendik Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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