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Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider

2026년 5월 18일 업데이트: Tugce Aydin Ozata, Istanbul University

Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider Target-Controlled Infusion Models. A Randomized Trial

This randomized prospective study aims to compare the effects of two target-controlled infusion models, the Schnider and Eleveld models, on anesthetic depth and hemodynamic responses during anesthesia induction in adult patients undergoing spinal surgery.

Patients scheduled for spinal surgery will be randomized into either the Schnider or Eleveld group. Before induction, standard monitoring will be applied, including electrocardiography, peripheral oxygen saturation, invasive arterial blood pressure monitoring, heart rate monitoring, and bispectral index monitoring. Anesthesia induction will be performed with fentanyl 2 mcg/kg, rocuronium 0.6 mg/kg, and propofol administered by target-controlled infusion with an effect-site target concentration of 3 mcg/mL according to the allocated pharmacokinetic model.

Hemodynamic parameters and bispectral index values will be recorded before induction and at the 1st, 3rd, 5th, and 10th minutes after induction. Additional parameters, including time to BIS below 40, time to delta activity, burst suppression duration, total propofol dose during the first 5 minutes, need for additional propofol, hemodynamic response to intubation, vasopressor requirement within the first 10 minutes, and use of esmolol, will also be documented. The primary aim is to evaluate whether the Schnider and Eleveld models differ in terms of induction-related hemodynamic stability and anesthetic depth during the early induction period.

연구 개요

상세 설명

This study is designed as a randomized prospective clinical study in adult patients undergoing spinal surgery. The study will evaluate and compare two pharmacokinetic models used for target-controlled infusion of propofol: the Schnider model and the Eleveld model. The main focus of the study is the first 10 minutes of anesthesia induction, a period in which rapid changes in anesthetic depth and hemodynamic variables may occur.

Eligible patients scheduled for spinal surgery will be assigned to one of two groups according to the propofol target-controlled infusion model used during induction: the Schnider group or the Eleveld group. Patients younger than 18 years, patients with uncontrolled hypertension, patients with uncontrolled diabetes mellitus, and patients who do not provide consent will be excluded.

Before anesthesia induction, demographic and clinical variables will be recorded, including age, sex, ASA physical status, height, weight, body mass index, diagnosis, type of operation, operation date, and comorbid diseases. Baseline vital signs will be obtained from the preoperative ward follow-up values and from the immediate pre-induction period.

All patients will receive standard monitoring before induction, including peripheral oxygen saturation, electrocardiography, invasive arterial blood pressure monitoring, heart rate monitoring, and bispectral index monitoring. Invasive arterial pressure monitoring will allow continuous assessment of systolic arterial pressure, diastolic arterial pressure, and mean arterial pressure during the induction period.

Anesthesia induction will be performed using fentanyl 2 mcg/kg, rocuronium 0.6 mg/kg, and propofol administered by target-controlled infusion. Propofol will be administered using the pharmacokinetic model assigned by randomization, either Schnider or Eleveld. The target-controlled infusion pump will be set to achieve an effect-site propofol concentration of 3 mcg/mL. The induction period will be evaluated during the first 10 minutes after induction.

Heart rate, mean arterial pressure, systolic arterial pressure, diastolic arterial pressure, and BIS values will be recorded at predefined time points: ward baseline, immediately before induction, and at the 1st, 3rd, 5th, and 10th minutes after induction. The presence of a hemodynamic response to intubation will be assessed according to whether heart rate or mean arterial pressure increases by more than 20% compared with ward measurements. Patient movement or straining during intubation will also be recorded as none, mild, or severe.

In addition to routine hemodynamic and BIS measurements, several induction-related variables will be documented. These include the time required for BIS to decrease below 40, the time until delta activity is observed, burst suppression duration, total propofol dose during the first 5 minutes, need for additional propofol, total fentanyl and rocuronium doses, and whether esmolol was used, including its dose. The requirement for vasopressor therapy within the first 10 minutes, including the agent and dose used, will also be recorded.

During the first 10 minutes of induction, magnesium administration will not be performed in order to avoid potential confounding effects on hemodynamic parameters. Throughout the operation, the patient's hemodynamic stability will be observed, and any additional drug requirements will be documented.

The primary objective of the study is to compare the Schnider and Eleveld target-controlled infusion models in terms of hemodynamic changes and anesthetic depth during the first 10 minutes of anesthesia induction. Secondary evaluations will include the incidence of intubation-related hemodynamic response, time to BIS below 40, burst suppression duration, need for additional propofol, vasopressor requirement, and total propofol dose during early induction.

연구 유형

관찰

등록 (추정된)

50

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

The study population will consist of adult patients scheduled for elective spinal surgery under general anesthesia at the Neurosurgery Department of Istanbul University, Istanbul Faculty of Medicine. Eligible patients will be 18 years of age or older and will provide written informed consent before enrollment.

Patients with uncontrolled hypertension, uncontrolled diabetes mellitus, those younger than 18 years of age, and patients who do not provide consent will be excluded from the study. Eligible participants will be randomized to receive propofol target-controlled infusion using either the Schnider or Eleveld model for anesthetic induction. Hemodynamic parameters and bispectral index values will be evaluated during the first 10 minutes of the induction period.

설명

Inclusion Criteria:

  • Patients scheduled for elective spinal surgery under general anesthesia
  • Patients who will undergo surgery at the Neurosurgery Department of Istanbul University, Istanbul Faculty of Medicine
  • Patients aged 18 years or older
  • Patients who provide written informed consent to participate in the study

Exclusion Criteria:

  • Patients with uncontrolled hypertension
  • Patients with uncontrolled diabetes mellitus
  • Patients younger than 18 years of age
  • Patients who do not provide informed consent to participate in the study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Eleveld Model
Eleveld model used patients
Patients in this group will receive propofol for anesthetic induction using target-controlled infusion based on the Eleveld pharmacokinetic/pharmacodynamic model. Standard monitoring will include electrocardiography, peripheral oxygen saturation, invasive arterial blood pressure, heart rate, and bispectral index monitoring. Fentanyl 2 mcg/kg and rocuronium 0.6 mg/kg will be administered according to the study protocol. Hemodynamic variables and BIS values will be recorded before induction and at 1, 3, 5, and 10 minutes after induction.
Schnider Model
Schnider model used patients
Patients randomized to the Schnider group will receive propofol for anesthetic induction using target-controlled infusion based on the Schnider pharmacokinetic/pharmacodynamic model. Propofol will be administered via a TCI system according to the study protocol. Standard monitoring will include electrocardiography, peripheral oxygen saturation, invasive arterial blood pressure, heart rate, and bispectral index monitoring. Fentanyl 2 mcg/kg and rocuronium 0.6 mg/kg will be administered as part of the standardized induction protocol. Hemodynamic variables and BIS values will be recorded before induction and at 1, 3, 5, and 10 minutes after induction.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Arterial Pressure - Physiological Parameter
기간: Mean Arterial Pressure - Baseline Mean Arterial Pressure - induction 1. minute Mean Arterial Pressure - induction 3. minute Mean Arterial Pressure - induction 5. minute Mean Arterial Pressure - induction 10. Minute
Mean Arterial Pressure Changes
Mean Arterial Pressure - Baseline Mean Arterial Pressure - induction 1. minute Mean Arterial Pressure - induction 3. minute Mean Arterial Pressure - induction 5. minute Mean Arterial Pressure - induction 10. Minute

2차 결과 측정

결과 측정
측정값 설명
기간
Heart Rate - Physiological Parameter
기간: Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute
Heart Rate Changes
Heart Rate - baseline Heart Rate- induction 1. minute Heart Rate- induction 3. minute Heart Rate- induction 5. minute Heart Rate- induction 10. minute
Bisepectal Index values - Physiological Parameter, Processed EEG
기간: baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute
Bisepectal Index values
baseline- intraoperative 0. minute induction - 1. minute induction- 3. minute induction- 5. minute induction- 10. Minute

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 18일

기본 완료 (추정된)

2026년 7월 30일

연구 완료 (추정된)

2026년 8월 30일

연구 등록 날짜

최초 제출

2026년 5월 8일

QC 기준을 충족하는 최초 제출

2026년 5월 8일

처음 게시됨 (실제)

2026년 5월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

The clinical data of this trial are available upon reasonable request to the corresponding author.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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