About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ASA physical status classification I-III
Scheduled for kyphoplasty under sedation in the prone position
Provision of written informed consent
Disqualifiers
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
Trial population
Patients aged 18 and over scheduled kyphoplasty in prone position
Trial design
Cohort
Prospective
Treatments tested in this trial
Target controlled infusion of propofol
Procedure/SurgeryIn 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
DeviceThe 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
Treatment groups
Trial outcomes
Primary outcomes
. Number of Hypoxic Episodes
Total number of episodes in which peripheral oxygen saturation drops below 90% during the procedure.(SpO₂ \< 90%)
Secondary outcomes
Anesthesia Quality Score (0-32)
Assessed using the Simplified Quality of Anesthesia Scoring System (Ding \& White), evaluating motor response, hemodynamic stability, and respiratory stability.
Integrated Pulmonary Index (IPI) Values
Composite index (1-10) integrating SpO₂, respiratory rate, EtCO₂, and heart rate measured via Capnostream® device.
Total Propofol Consumption
Total amount of propofol administered during the procedure (mg).
Time to Eye Opening
Time in minutes from end of the procedure to spontaneous eye opening.
Sponsors and contacts
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