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

NCT07745348 | Not Yet Recruiting

• 1 other identifier: MJR KYPHO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kyphoplasty; Prone Position; End Tidal Carbon Dioxide; Target Controlled Infusion of Propofol

Keywords

target controlled infusion; kyphoplasty; sedation; non-invasive etco2

Outcome Measures

Primary Outcomes (1)

• . Number of Hypoxic Episodes

  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

Secondary Outcomes (5)

• Anesthesia Quality Score (0-32)

  from sedation initiation to end of procedure, Intraoperatively.

• Integrated Pulmonary Index (IPI) Values

  Every 10 minutes intraoperatively, during sedation procedures

• Total Propofol Consumption

  Intraoperatively, from sedation initiation to end of procedure

• Time to Eye Opening

  From end of procedure to first eye opening, up to 10 minutes

• Surgeon Satisfaction

  end of the procedure.

Study Arms (2)

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.

Device: non invasive ETCO2 monitoring

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

Procedure: Target controlled infusion of propofol; Device: non invasive ETCO2 monitoring

Interventions

non invasive ETCO2 monitoring DEVICE

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 TIVA; group TCI

Target controlled infusion of propofol PROCEDURE

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.

group TCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 and over scheduled kyphoplasty in prone position

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Seniyye Ülgen Zengin

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Related Publications (3)

• Ding Y, White PF. Simplified quality of anaesthesia scoring system. Anaesthesia. 1992 Oct;47(10):906-7. doi: 10.1111/j.1365-2044.1992.tb03166.x. No abstract available.

  PMID: 1294143 BACKGROUND

• Sandler NA, Hodges J, Sabino M. Assessment of recovery in patients undergoing intravenous conscious sedation using bispectral analysis. J Oral Maxillofac Surg. 2001 Jun;59(6):603-11; discussion 611-2. doi: 10.1053/joms.2001.23366.

  PMID: 11381378 BACKGROUND

• Chang YT, Tsai TC, Hsu H, Chen YM, Chi KP, Peng SY. Sedation for gastrointestinal endoscopy with the application of target-controlled infusion. Turk J Gastroenterol. 2015 Sep;26(5):417-22. doi: 10.5152/tjg.2015.0206.

  PMID: 26350688 BACKGROUND

Central Study Contacts

dilara göçmen, asst prof

CONTACT

+90 5413439438; dilara.gocmen@marmara.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: August 4, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): August 10, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)