Comparison of Sevoflurane and Desflurane on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Analgesia Nociception Index (ANI) From 1 Minute Before to 1 Minute After Tetanic Stimulation
研究概览
简要总结
This prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Participants will be randomized to maintenance anesthesia with either sevoflurane or desflurane, and ANI responses to a standardized nociceptive stimulus will be measured under equi-minimum alveolar concentration (age-adjusted 1.0 MAC) conditions. The primary objective is to compare the change in ANI before and after tetanic stimulation between the two anesthetic groups. Secondary measurements will include bispectral index, blood pressure, heart rate, and end-tidal anesthetic concentration around the time of stimulation.
详细描述
This prospective randomized controlled study will compare the effects of sevoflurane and desflurane on the Analgesia Nociception Index (ANI) in adult patients undergoing general anesthesia. Conventional indicators of intraoperative nociception, such as changes in blood pressure, heart rate, and patient movement, can be influenced by anesthetic depth, vasoactive agents, and intravascular volume status. ANI is a heart rate variability-based monitoring index developed to provide a more objective assessment of nociception during general anesthesia. Previous studies have suggested that sevoflurane and desflurane may produce different nociceptive responses at equi-minimum alveolar concentration (MAC), but comparative data using ANI are lacking. In this study, eligible patients will be randomized to maintenance anesthesia with either sevoflurane or desflurane. After standardized induction and stabilization at age-adjusted 1.0 MAC, a standardized tetanic stimulation will be applied, and ANI will be recorded 1 minute before and 1 minute after stimulation. The primary objective is to compare the between-group difference in ANI change in response to the same nociceptive stimulus under equi-MAC conditions. Secondary assessments will include bispectral index, blood pressure, and heart rate measured around the time of stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 to 79 years
- •Patients undergoing general anesthesia
- •American Society of Anesthesiologists (ASA) physical status I or II
排除标准
- •History of taking medications that may affect the central nervous system or autonomic nervous system (e.g., anticholinergics, beta-blockers, antidepressants, anxiolytics, hypnotics, or analgesics)
- •Known hypersensitivity to sevoflurane, desflurane, or other halogenated anesthetics, or a personal or family history of malignant hyperthermia
- •Neurologic or psychiatric disorders (e.g., depression, dementia, or cerebral infarction)
- •Arrhythmia
- •Diabetes mellitus
- •Drug abuse or alcohol abuse
- •Vulnerable subjects
- •Patients aged 80 years or older
- •Patients with impaired consciousness or those judged to lack the capacity to provide informed consent
研究组 & 干预措施
Sevoflurane
Participants randomized to this arm will receive sevoflurane for maintenance of general anesthesia after standardized induction with lidocaine, propofol target-controlled infusion, and rocuronium. End-tidal sevoflurane concentration will be adjusted to maintain age-adjusted 1.0 minimum alveolar concentration (MAC) before standardized tetanic stimulation. ANI, BIS, blood pressure, and heart rate will be recorded before and after stimulation.
干预措施: Sevoflurane (Drug)
Desflurane
Participants randomized to this arm will receive desflurane for maintenance of general anesthesia after standardized induction with lidocaine, propofol target-controlled infusion, and rocuronium. End-tidal desflurane concentration will be adjusted to maintain age-adjusted 1.0 minimum alveolar concentration (MAC) before standardized tetanic stimulation. ANI, BIS, blood pressure, and heart rate will be recorded before and after stimulation.
干预措施: Desflurane (Drug)
结局指标
主要结局
Change in Analgesia Nociception Index (ANI) From 1 Minute Before to 1 Minute After Tetanic Stimulation
时间窗: From 1 minute before tetanic stimulation to 1 minute after tetanic stimulation
ANI will be measured 1 minute before and 1 minute after standardized tetanic stimulation. The primary analysis will compare the between-group difference in ANI change from before to after stimulation.
次要结局
- Bispectral Index (BIS)(Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation)
- Blood Pressure(Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation)
- Heart Rate(Before induction of anesthesia, 1 minute before tetanic stimulation, and 1 minute after tetanic stimulation)