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

3 augusti 2026 uppdaterad av: Marmara University Pendik Training and Research Hospital

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

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

50

Kontakter och platser

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Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients aged 18 and over scheduled kyphoplasty in prone position

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Group TIVA
Patients receiving sedation via conventional manually administered total intravenous anesthesia (TIVA). Propofol 1% is administered by the anesthesiologist via manual boluses as needed, guided by BIS values, hemodynamic variables, and clinical assessment.
Enhet: 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
group TCI
Patients receiving sedation via target-controlled infusion (TCI) using the Schnider pharmacokinetic model. Propofol 1% is administered via TCI device with patient-specific parameters (height, weight, age, sex) entered. Plasma target concentration is titrated between 0.5-3 µg/mL. Sedation depth is adjusted according to BIS values and hemodynamic responses
Enhet: 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
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
. Number of Hypoxic Episodes
Tidsram: 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%)
from sedation initiation to end of procedure,Intraoperatively

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anesthesia Quality Score (0-32)
Tidsram: 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.
from sedation initiation to end of procedure, Intraoperatively.
Integrated Pulmonary Index (IPI) Values
Tidsram: Every 10 minutes intraoperatively, during sedation procedures
Composite index (1-10) integrating SpO₂, respiratory rate, EtCO₂, and heart rate measured via Capnostream® device.
Every 10 minutes intraoperatively, during sedation procedures
Total Propofol Consumption
Tidsram: Intraoperatively, from sedation initiation to end of procedure
Total amount of propofol administered during the procedure (mg).
Intraoperatively, from sedation initiation to end of procedure
Time to Eye Opening
Tidsram: From end of procedure to first eye opening, up to 10 minutes
Time in minutes from end of the procedure to spontaneous eye opening.
From end of procedure to first eye opening, up to 10 minutes
Surgeon Satisfaction
Tidsram: end of the procedure.
Assessed on a 4-point scale: very good, good, fair, poor.
end of the procedure.

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Sponsor

Marmara University Pendik Training and Research Hospital

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 juli 2026

Primärt slutförande (Beräknad)

10 juli 2027

Avslutad studie (Beräknad)

10 augusti 2027

Studieregistreringsdatum

Först inskickad

5 juli 2026

Först inskickad som uppfyllde QC-kriterierna

3 augusti 2026

Första postat (Faktisk)

4 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • MJR KYPHO

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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