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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University Pendik Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Target controlled infusion of propofol

    Procedure/Surgery

    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.

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group TIVA1 intervention
Group B: group TCI2 interventions

Trial outcomes

Primary outcomes

1

. 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

Secondary outcomes

1

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.
2

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
3

Total Propofol Consumption

Total amount of propofol administered during the procedure (mg).

Time frame
Intraoperatively, from sedation initiation to end of procedure
4

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

Other outcomes

Sponsors and contacts

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