A Study of the Correlation Between the Debilitating State of the Elderly and Propofol Sensitivity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- telomere length
研究概览
简要总结
In an aging society, there is a surge in the number of surgeries for elderly patients in hospitals, and the elderly are at greater risk of anesthesia due to their own characteristics: slowing metabolism, decreasing resistance, and decreasing physical function, and increased sensitivity to propofol. However, there are large individual differences, and anesthesiologists have found that they cannot judge a patient's sensitivity to anesthetic drugs based on age alone. Patients with different levels of debilitation have different sensitivities to propofol. The use of measuring telomere length to assess the debilitating state of the elderly is a novel and reliable assessment method. Then the sensitivity to propofol of people with different debilitating states was studied, so as to guide anesthesiologists to use drugs safely and reasonably, with a view to realizing the purpose of precise anesthesia.
详细描述
Part I: A study of the correlation between telomere length and somatic debilitation status in older adults Telomere length was measured by fluorescent quantitative PCR, and subjects were assessed for somatic frailty using the Edmonton Scale (EFS).
- Perform a correlation analysis between telomere length and Edmonton debility score.
- Comparison of telomere length differences between Edmonton debility subgroups.
- Subjects were categorized into "not debilitated" and "debilitated" dichotomous variables according to Edmonton debilitation ratings. The strength of the predictive power of telomere length for frailty was determined using the area under the ROC curve (AUC) using the operator operating characteristic curve ROC treatment .
Part II: Correlation between telomere length and propofol sensitivity in elderly surgical patients A total of 128 patients undergoing lower limb surgery under subarachnoid block in the Second Hospital of Shanxi Medical University were selected and divided into non-frailty group and frailty group.Propofol was pumped at a rate of 20 mg/kg/h with a micropump at 15 minutes after subarachnoid block, and the pumping rate was reduced to 10 mg/kg/h after 1 minute.Stop the infusion when consciousness is absent and observe the time of loss of consciousness (time of loss of eyelash reflex).
intraoperative recording of the time of loss of consciousness (time of disappearance of eyelash reflex), time of awakening, and dosage of propofol in both groups; recording of the time of admission to the room (T0), the time after completion of subarachnoid blockade (T1), the time after 1min of pumping propofol (T2), the time after 5min of pumping propofol (T3), the time after 10min of pumping propofol (T4), the time after 15min of pumping propofol ( T5), after pumping propofol for 20 min (T6), after pumping propofol for 25 min (T7), and after pumping propofol for 30 min (T8); mean arterial pressure (MAP), heart rate (HR), and electroencephalographic dual-frequency index (BIS value) at nine time points; the incidence of adverse reactions (hypotension, bradycardia, and respiratory depression) was recorded for the two groups.
Research hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •American Society of Anesthesiologists (ASA) Classification I-IV
- •No previous history of central nervous system disease, no history of psychiatric disorders, no contraindications to anesthesia
- •No use of sedative drugs or opioids within 24h
- •Approval and consent by the Ethics Committee of Shanxi Medical University and written informed consent by the patient (or authorized delegate)
排除标准
- •leukemia patient
- •Patients with hearing and visual impairments, communication disorders, inability to complete the debilitating state test
- •Patient or family refused to participate in this study
研究组 & 干预措施
non-frail group
Edmonton scores zero to three
干预措施: propofol (Drug)
frail group
Edmonton scores three or more points
干预措施: propofol (Drug)
结局指标
主要结局
telomere length
时间窗: 24 hours
Differences in telomere length
Propofol dosage
时间窗: 24 hours
Differences in Propofol dosage
Loss of consciousness time
时间窗: 24 hours
Differences in loss of consciousness time
awakening time
时间窗: 24 hours
Differences in awakening time
Mean Arterial Pressure (MAP)
时间窗: 24 hours
Differences in Mean Arterial Pressure (MAP)
heart rate
时间窗: 24 hours
Differences in heart rate
Electroencephalographic dual frequency index (BIS value)
时间窗: 24 hours
Differences in Electroencephalographic dual frequency index (BIS value)
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
时间窗: 24 hours
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
次要结局
- Use of vasoactive drugs(24 hours)
研究者
Zheng Guo
professor
Second Hospital of Shanxi Medical University