TCI Versus Manual TIVA for Sedation During Prone Kyphoplasty: Effects on Respiration, Recovery, and EEG
Investigation of the Effects of Target-Controlled Infusion (TCI) Anesthesia on Respiration, Recovery, and Electroencephalogram in Patients Undergoing Kyphoplasty in the Prone Position
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: dilara göçmen, asst prof
- Phone Number: +90 5413439438
- Email: dilara.gocmen@marmara.edu.tr
Study Locations
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Maltepe
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Istanbul, Maltepe, Turkey (Türkiye), 34854
- Seniyye Ülgen Zengin
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Contact:
- seniyye ülgen zengin, assoc prof
- Phone Number: +90 216 606 11 41
- Email: suzengin@marmara.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 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
|
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
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
. 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%)
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from sedation initiation to end of procedure,Intraoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anesthesia Quality Score (0-32)
Time Frame: from sedation initiation to end of procedure, Intraoperatively.
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Assessed using the Simplified Quality of Anesthesia Scoring System (Ding & White), evaluating motor response, hemodynamic stability, and respiratory stability.
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from sedation initiation to end of procedure, Intraoperatively.
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Integrated Pulmonary Index (IPI) Values
Time Frame: Every 10 minutes intraoperatively, during sedation procedures
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Composite index (1-10) integrating SpO₂, respiratory rate, EtCO₂, and heart rate measured via Capnostream® device.
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Every 10 minutes intraoperatively, during sedation procedures
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Total Propofol Consumption
Time Frame: Intraoperatively, from sedation initiation to end of procedure
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Total amount of propofol administered during the procedure (mg).
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Intraoperatively, from sedation initiation to end of procedure
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Time to Eye Opening
Time Frame: From end of procedure to first eye opening, up to 10 minutes
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Time in minutes from end of the procedure to spontaneous eye opening.
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From end of procedure to first eye opening, up to 10 minutes
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Surgeon Satisfaction
Time Frame: end of the procedure.
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Assessed on a 4-point scale: very good, good, fair, poor.
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end of the procedure.
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Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MJR KYPHO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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