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Not Yet Recruiting NCT07745348

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

Conditions: Kyphoplasty, Prone Position, Target Controlled Infusion of Propofol, End Tidal Carbon Dioxide

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 50
Sponsor: Marmara University Pendik Training and Research Hospital

Location: Seniyye Ülgen Zengin Istanbul Maltepe

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07745348). StuddyBuddy aggregates publicly available trial information.