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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: dilara göçmen, asst prof
- 전화번호: +90 5413439438
- 이메일: dilara.gocmen@marmara.edu.tr
연구 장소
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Maltepe
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Istanbul, Maltepe, 터키 (Türkiye), 34854
- Seniyye Ülgen Zengin
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연락하다:
- seniyye ülgen zengin, assoc prof
- 전화번호: +90 216 606 11 41
- 이메일: suzengin@marmara.edu.tr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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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.
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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
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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
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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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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. Number of Hypoxic Episodes
기간: from sedation initiation to end of procedure,Intraoperatively
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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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anesthesia Quality Score (0-32)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
스폰서
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- MJR KYPHO
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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