An observational study in Kyphoplasty, Prone Position and Target Controlled Infusion of Propofol, sponsored by Marmara University Pendik Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Marmara University Pendik Training and Research Hospital · Observational
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.
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.
Marmara University Pendik Training and Research Hospital is the lead sponsor of 34 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 and over scheduled kyphoplasty in prone position
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Age 18 years and older
Exclusion Criteria:
Known allergy to any of the study medications
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: non invasive ETCO2 monitoring
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
Procedure: Target controlled infusion of propofol · Device: non invasive ETCO2 monitoring
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.
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
. Number of Hypoxic Episodes
Total number of episodes in which peripheral oxygen saturation drops below 90% during the procedure.(SpO₂ \< 90%)
Time frame: from sedation initiation to end of procedure,Intraoperatively
Anesthesia Quality Score (0-32)
Assessed using the Simplified Quality of Anesthesia Scoring System (Ding \& White), evaluating motor response, hemodynamic stability, and respiratory stability.
Time frame: from sedation initiation to end of procedure, Intraoperatively.
Integrated Pulmonary Index (IPI) Values
Composite index (1-10) integrating SpO₂, respiratory rate, EtCO₂, and heart rate measured via Capnostream® device.
Time frame: Every 10 minutes intraoperatively, during sedation procedures
Total Propofol Consumption
Total amount of propofol administered during the procedure (mg).
Time frame: Intraoperatively, from sedation initiation to end of procedure
Time to Eye Opening
Time in minutes from end of the procedure to spontaneous eye opening.
Time frame: From end of procedure to first eye opening, up to 10 minutes
Surgeon Satisfaction
Assessed on a 4-point scale: very good, good, fair, poor.
Time frame: end of the procedure.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
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Marmara University Pendik Training and Research Hospital