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临床试验/NCT06558695
NCT06558695已完成不适用

Comparison of TIVA and Sevoflurane: Affirming Hemodynamic, Respiratory, and Neuromonitoring Stability in Prone Position Spinal Surgeries

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
ETCO2

研究概览

简要总结

Key Points:

  1. Objective:

o To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries. 2. Methodology:

  • A randomized controlled trial involving 52 patients scheduled for lumbar spine surgery, randomly assigned to either TIVA or sevoflurane groups.
  • Respiratory and hemodynamic parameters were measured at various time points.
  1. Results:
  • No significant differences were found between the TIVA and sevoflurane groups in terms of respiratory mechanics or hemodynamic stability.
  • Both anesthesia techniques maintained stable intraoperative conditions.
  1. Clinical Implications:
  • Anesthesiologists can flexibly choose between TIVA and sevoflurane based on patient-specific factors and surgical requirements.
  • TIVA may be preferred in surgeries with high neurological risk due to its compatibility with neuromonitoring.
  1. Future Research:
  • Studies with broader patient populations and long-term outcomes are needed to further refine anesthesia management strategies.
  • Research on the environmental impact and cost-effectiveness of anesthesia techniques is also important.

详细描述

This study aims to evaluate the impact of total intravenous anesthesia (TIVA) versus sevoflurane anesthesia on respiratory mechanics and hemodynamic parameters during spinal surgery performed in the prone position. Anesthesia management for spinal surgeries in the prone position is particularly challenging due to significant physiological changes. Identifying the effects of different anesthesia techniques is essential to enhance patient outcomes and ensure intraoperative stability. This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants were randomly assigned to one of two groups using a computer-generated list: the Sevoflurane group (Sevo group) and the Total Intravenous Anesthesia group (TIVA group), each comprising 26 patients. The assignment and subsequent anesthesia management were conducted in a double-blinded manner, ensuring that neither the patients nor the clinicians administering the treatments or assessing the outcomes were aware of the group allocations

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study included male and female patients aged 18 to 65 years who were scheduled for lumbar spine surgery under general anesthesia. Patients were categorized based on the American Society of Anesthesiologists (ASA) physical status levels I, II, and III.

排除标准

  • Diagnosis of asthma or chronic obstructive pulmonary disease (COPD)
  • Major cardiac conditions, such as recent myocardial infarction or a left ventricular ejection fraction (EF) less than 55%
  • Atrioventricular blocks of second and third degrees
  • Allergies to any drugs
  • Severe neurological disorders
  • History of sedative or opioid use

研究组 & 干预措施

Sevoflurane Group

Active Comparator

In the Sevoflurane group, general anesthesia was maintained with sevoflurane at 0.8-1.0 minimum alveolar concentration (MAC).

干预措施: Sevoflurane (Drug)

TIVA group

Active Comparator

In the TIVA (Total Intra Venous Anesthesia) group, a combination of propofol (50-150 μg/kg/min) and remifentanil (0.02-0.2 μg/kg/min) was used for general anesthesia instead of inhalational agents.

干预措施: TIVA (Drug)

结局指标

主要结局

ETCO2

时间窗: 5, 15, and 30 minutes after positioning in the prone position

end-tidal carbon dioxide

Pmean

时间窗: 5, 15, and 30 minutes after positioning in the prone position

mean airway pressure

Vd/Vt

时间窗: in the prone position at the 30th minute

dead space/tidal volume

PaO2/FiO2

时间窗: in the prone position at the 30th minute

Partial Oxygen pressure/traction of inspired oxygen

PEEP

时间窗: 5, 15, and 30 minutes after positioning in the prone position

positive end-expiratory pressure

VT

时间窗: 5, 15, and 30 minutes after positioning in the prone position

tidal volume

Ppeak

时间窗: 5, 15, and 30 minutes after positioning in the prone position

peak airway pressure

RR

时间窗: 5, 15, and 30 minutes after positioning in the prone position

Respiratory Rate

Cdyn

时间窗: in the supine position after intubation and in the prone position at the 30th minute

Dynamic. compliance

MV

时间窗: 5, 15, and 30 minutes after positioning in the prone position

Minute volume

次要结局

  • SBP(5, 15, and 30 minutes after positioning in the prone position)
  • HR(5, 15, and 30 minutes after positioning in the prone position)
  • DBP(5, 15, and 30 minutes after positioning in the prone position)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YÜCEL YÜCE

Associate Professor

Saglik Bilimleri Universitesi

研究点 (1)

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