Evaluation of Equivalent Minimum Alveolar Concentration During General Anesthesia: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Correlation between Equivalent Minimum Alveolar Concentration (eMAC) and Minimum Alveolar Concentration (MAC)
研究概览
简要总结
This observational study aims to evaluate the clinical applicability of the Equivalent Minimum Alveolar Concentration (eMAC) parameter during general anesthesia. eMAC is a recently developed index that combines the effects of both inhalational and intravenous anesthetics, providing a unified measure of anesthetic depth. While the traditional Minimum Alveolar Concentration (MAC) is widely used for inhalational agents, it does not reflect intravenous anesthetics or combined techniques such as Combined Intravenous and Inhalational Anesthesia (CIVIA).
In this study, adult patients undergoing elective surgery under general anesthesia will be observed. Standard clinical practice will not be altered. Demographic and clinical parameters, including eMAC, MAC, Bispectral Index (BIS), and hemodynamic variables, will be recorded at defined perioperative time points. No experimental drugs or additional procedures will be administered.
The primary aim is to investigate the correlation between eMAC and MAC values obtained during anesthesia. Secondary objectives include assessing the relationship between eMAC and BIS values, comparing eMAC, MAC, and BIS across different anesthetic techniques, and evaluating hemodynamic stability in relation to anesthetic depth.
The results of this study may contribute to a better understanding of eMAC and its potential role in clinical anesthesia practice.
详细描述
This is a prospective, observational study designed to evaluate the Equivalent Minimum Alveolar Concentration (eMAC) parameter during general anesthesia. eMAC is a composite index that incorporates the anesthetic effects of both inhalational agents and intravenous anesthetics, such as propofol and remifentanil, allowing assessment of anesthetic depth under combined techniques (CIVIA). While the traditional Minimum Alveolar Concentration (MAC) is well established for inhalational agents, its applicability is limited in cases where intravenous agents are administered. eMAC has been proposed as a more comprehensive measure, but clinical validation is lacking.
Adult patients (ages 18-65, ASA I-III) scheduled for elective surgical procedures under general anesthesia will be enrolled. No experimental interventions will be performed; anesthetic management will follow routine clinical practice. Participants will be observed in two groups, based on the anesthetic technique selected by the attending anesthesiologist.
Data collection will include demographic and baseline clinical variables, as well as anesthetic depth parameters (eMAC, MAC, Bispectral Index [BIS]) and hemodynamic variables (heart rate, mean arterial pressure, SpO₂). Measurements will be recorded at predefined time points: prior to induction (T0), 5 minutes after induction (T1), at the beginning of surgery (T2), at the midpoint of surgery (T3), and at the end of surgery (T4).
The primary outcome measure is the correlation between eMAC and MAC values obtained during anesthesia. Secondary outcome measures include the correlation between eMAC and BIS values, comparisons of eMAC, MAC, and BIS among different anesthetic techniques, and evaluation of hemodynamic stability in relation to anesthetic depth.
Statistical analysis will be performed using appropriate parametric or non-parametric tests, depending on the distribution of variables. Correlation analyses will be conducted using Pearson or Spearman methods, and the impact of demographic factors on eMAC will be explored using multivariate regression. A p-value <0.05 will be considered statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Adults aged 18-65 years
- •Scheduled for elective surgery under general anesthesia
- •American Society of Anesthesiologists (ASA) Physical Status I-III
- •Feasibility of Bispectral Index (BIS) monitoring
- •Provision of written informed consent
排除标准
- •History of neurological disease (e.g., epilepsy, dementia, severe brain injury)
- •Known allergy to anesthetic agents
- •Severe cardiovascular or respiratory failure
研究组 & 干预措施
Inhalational Anesthesia Group
Patients receiving general anesthesia maintained with inhalational agents (e.g., sevoflurane) according to standard clinical practice.
干预措施: Sevoflurane + Remifentanil (Drug)
Combined Intravenous-Inhalational Anesthesia (CIVIA) Group
Patients receiving general anesthesia with a combination of intravenous and inhalational agents according to standard clinical practice.
干预措施: Sevoflurane + Propofol + Remifentanil (Drug)
结局指标
主要结局
Correlation between Equivalent Minimum Alveolar Concentration (eMAC) and Minimum Alveolar Concentration (MAC)
时间窗: From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery)
To determine the relationship between eMAC values and conventional MAC values obtained from the anesthesia workstation.
次要结局
- Correlation between eMAC and Bispectral Index (BIS)(From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery))
- Comparison of eMAC, MAC, and Bispectral Index (BIS) Values Measured by Anesthesia Workstation and BIS Monitor Across Different Anesthetic Techniques(From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery))
- Heart Rate During Anesthesia(From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery))
- Mean Arterial Pressure During Anesthesia(From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery))
- Peripheral Oxygen Saturation (SpO₂) During Anesthesia(From induction of anesthesia until the end of surgery (measured at five perioperative time points: prior to induction, 5 minutes after induction, at surgical incision, at the midpoint of surgery, and at the end of surgery))
研究者
Ayça Taş Tuna
Prof.Dr.
Sakarya University