KyphoplastyNCT07745348
TCI Versus Manual TIVA for Sedation During Prone Kyphoplasty: Effects on Respiration, Recovery, and EEG
An observational study of Kyphoplasty and Prone Position, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kyphoplasty, Prone Position, Target Controlled Infusion of Propofol
- What is being tested?
- non invasive ETCO2 monitoring
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2026to 10 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 and over scheduled kyphoplasty in prone position
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Seniyye Ülgen Zengin
Istanbul, Maltepe, 34854
seniyye ülgen zengin, assoc prof, +90 216 606 11 41, suzengin@marmara.edu.tr
About this study
Official title: Investigation of the Effects of Target-Controlled Infusion (TCI) Anesthesia on Respiration, Recovery, and Electroencephalogram in Patients Undergoing Kyphoplasty in the Prone Position
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.
Read the detailed description
Kyphoplasty is a minimally invasive spinal procedure commonly performed for osteoporotic vertebral compression fractures. The procedure involves balloon elevation of the collapsed vertebral body followed by injection of polymethylmethacrylate (PMMA) bone cement for stabilization. The procedure is performed in the prone position and typically involves 1-2 vertebral levels.
Total intravenous anesthesia (TIVA), using combinations of propofol and remifentanil, is an alternative to inhalation anesthesia. TIVA can be administered manually or via target-controlled infusion (TCI) systems. TCI systems use pharmacokinetic models to achieve and maintain targeted plasma or effect-site concentrations. Studies in endoscopy settings have demonstrated that TCI-based sedation provides more stable sedation depth, fewer hemodynamic fluctuations, and faster recovery compared to manual administration.
Kyphoplasty procedures are typically performed in elderly patients with multiple comorbidities in the prone position under fluoroscopic guidance. The prone position, while mandatory for kyphoplasty, presents significant anesthesia management challenges: limited airway access increases the risk of respiratory depression during sedation, and chest compression impairs ventilation mechanics and may reduce alveolar ventilation. Therefore, meticulous respiratory monitoring during kyphoplasty is essential.
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. Additionally, bispectral index (BIS) monitoring enables objective tracking of anesthesia depth through EEG waveform analysis.
This study aims to compare manual TIVA versus TCI methods regarding sedation depth, respiratory stability, hemodynamic parameters, and recovery in patients undergoing kyphoplasty in the prone position. The findings are expected to contribute to determining the optimal anesthesia approach in this patient population.
- Conditions
- Kyphoplasty, Prone Position, Target Controlled Infusion of Propofol, End Tidal Carbon Dioxide
- Being tested
- Target controlled infusion of propofol, non invasive ETCO2 monitoring
- Keywords
- target controlled infusion, kyphoplasty, sedation, non-invasive etco2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target controlled infusion of propofolProcedure or 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 monitoringDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Target controlled infusion of propofol; Device: non invasive ETCO2 monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
. Number of Hypoxic Episodes
Total number of episodes in which peripheral oxygen saturation drops below 90% during the procedure.(SpO₂ < 90%)
Measured: from sedation initiation to end of procedure,Intraoperatively
Secondary outcomes (5)
Anesthesia Quality Score (0-32)
Assessed using the Simplified Quality of Anesthesia Scoring System (Ding \& White), evaluating motor response, hemodynamic stability, and respiratory stability.
Measured: from sedation initiation to end of procedure, Intraoperatively.
Integrated Pulmonary Index (IPI) Values
Composite index (1-10) integrating SpO₂, respiratory rate, EtCO₂, and heart rate measured via Capnostream® device.
Measured: Every 10 minutes intraoperatively, during sedation procedures
Total Propofol Consumption
Total amount of propofol administered during the procedure (mg).
Measured: Intraoperatively, from sedation initiation to end of procedure
Time to Eye Opening
Time in minutes from end of the procedure to spontaneous eye opening.
Measured: From end of procedure to first eye opening, up to 10 minutes
Surgeon Satisfaction
Assessed on a 4-point scale: very good, good, fair, poor.
Measured: end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for KyphoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745348
- Sponsor's protocol ID
- MJR KYPHO
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1294143Sandler 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.
PubMed 11381378Chang 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.
PubMed 26350688
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Target-Controlled Infusion (TCI) Anesthesia on Respiration, Recovery, and Electroencephalogram in Patients Undergoing Kyphoplasty in the Prone Position
- ClinicalTrials.gov ID
- NCT07745348
- Acronym / sponsor ID
- MJR KYPHO
- Conditions
- Kyphoplasty, Prone Position, Target Controlled Infusion of Propofol, End Tidal Carbon Dioxide
- Keywords
- target controlled infusion, kyphoplasty, sedation, non-invasive etco2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Kyphoplasty is a minimally invasive spinal procedure commonly performed for osteoporotic vertebral compression fractures. The procedure involves balloon elevation of the collapsed vertebral body followed by injection of polymethylmethacrylate (PMMA) bone cement for stabilization. The procedure is performed in the prone position and typically involves 1-2 vertebral levels.
Total intravenous anesthesia (TIVA), using combinations of propofol and remifentanil, is an alternative to inhalation anesthesia. TIVA can be administered manually or via target-controlled infusion (TCI) systems. TCI systems use pharmacokinetic models to achieve and maintain targeted plasma or effect-site concentrations. Studies in endoscopy settings have demonstrated that TCI-based sedation provides more stable sedation depth, fewer hemodynamic fluctuations, and faster recovery compared to manual administration.
Kyphoplasty procedures are typically performed in elderly patients with multiple comorbidities in the prone position under fluoroscopic guidance. The prone position, while mandatory for kyphoplasty, presents significant anesthesia management challenges: limited airway access increases the risk of respiratory depression during sedation, and chest compression impairs ventilation mechanics and may reduce alveolar ventilation. Therefore, meticulous respiratory monitoring during kyphoplasty is essential.
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. Additionally, bispectral index (BIS) monitoring enables objective tracking of anesthesia depth through EEG waveform analysis.
This study aims to compare manual TIVA versus TCI methods regarding sedation depth, respiratory stability, hemodynamic parameters, and recovery in patients undergoing kyphoplasty in the prone position. The findings are expected to contribute to determining the optimal anesthesia approach in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TIVA | – | Device: non invasive ETCO2 monitoringPatients 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. |
| group TCI | – | Procedure: Target controlled infusion of propofol, Device: non invasive ETCO2 monitoringPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 and over scheduled kyphoplasty in prone position
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Known allergy to any of the study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target controlled infusion of propofolIn 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. | Procedure or surgery | group TCI |
| non invasive ETCO2 monitoringThe 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 | Device | Group TIVA, group TCI |
Primary outcome
. Number of Hypoxic Episodes
Time frame: from sedation initiation to end of procedure,Intraoperatively
Total number of episodes in which peripheral oxygen saturation drops below 90% during the procedure.(SpO₂ < 90%)
5 secondary outcomes
Anesthesia Quality Score (0-32)
Time frame: from sedation initiation to end of procedure, Intraoperatively.
Integrated Pulmonary Index (IPI) Values
Time frame: Every 10 minutes intraoperatively, during sedation procedures
Total Propofol Consumption
Time frame: Intraoperatively, from sedation initiation to end of procedure
Time to Eye Opening
Time frame: From end of procedure to first eye opening, up to 10 minutes
Surgeon Satisfaction
Time frame: end of the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 1294143Ding 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.
- Background: PubMed 11381378Sandler 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.
- Background: PubMed 26350688Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kyphoplasty and Prone Position, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dilara göçmen, asst prof (+90 5413439438, dilara.gocmen@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
. Number of Hypoxic Episodes (time frame: from sedation initiation to end of procedure,Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07745348, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.