Clinical Trial

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

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Summary
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.
Trial Details
NCT Number NCT07745348
Lead Sponsor Marmara University Pendik Training and Research Hospital
Conditions Kyphoplasty, Prone Position, Target Controlled Infusion of Propofol, End Tidal Carbon Dioxide
Enrollment 50 participants
Start Date 2026-07-10
Primary Completion 2027-07-10 (estimated)
Study Completion 2027-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-04