Comparison of Deep Hypnotic Time Duration in Geriatric Patients Undergoing General Anesthesia With Additional Bispectral Index Monitoring Compared to Standard Monitoring at Cipto Mangunkusumo Hospital in 2023
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Deep Hypnotic time duration with Bispectral Index Monitoring
研究概览
简要总结
Without adequate monitoring, administration of anesthetic agents can create unnecessary deeper anesthetic plane in geriatric population. This study aims to compare the duration of deep hypnotic time (DHT) in geriatric patients undergoing general anesthesia with additional BIS monitor compared to standard monitoring. This study was a randomized clinical trial involving 44 geriatric patients undergoing general anesthesia. Subjects are divided into two groups, one with additional BISTM monitor and the other with standard monitoring. Data acquired from BISTM will continually be recorded to be analyzed afterward
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 61 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sampling was consecutively conducted on geriatric patients aged >60 years undergoing general anesthesia for procedures lasting >2 hours with ASA physical status 1-3 and willing to participate in the study
排除标准
- •Exclusion criteria included intracranial procedures, unstable hemodynamic conditions, neurocognitive impairment, and if the patient was anticipated not to be extubated at the end of the surgical procedure. Patients could be excluded if the preoperative MMSE score was <24, undergoing general anesthesia using a combination of ketamine and/or N20 agents, experiencing emergencies during surgery, and losing BIS data >10% of the duration of the operation
研究组 & 干预措施
Experimental monitoring group with BIS
Subjects who meet the study criteria and has signed the inform consent will be randomized in a 1:1 ratio into 2 groups, namely Group A undergoing general anesthesia with additional BIS monitoring. When the patient arrives in the preparation room approximately 1 hour before surgery, MMSE evaluation is conducted to obtain preoperative MMSE data. Before anesthesia induction, monitoring and BIS sensor placement are performed
干预措施: Bispectral index monitor (Other)
Control monitoring group without BIS
Subjects who meet the study criteria and has signed the inform consent will be randomized in a 1:1 ratio into 2 groups, Group B undergoing general anesthesia with standard monitoring according to ASA. When the patient arrives in the preparation room approximately 1 hour before surgery, MMSE evaluation is conducted to obtain preoperative MMSE data. The BIS monitor for patients in Group B is then covered (hidden BIS), so that the data cannot be viewed by the anesthesia team performing the anesthesia
结局指标
主要结局
Deep Hypnotic time duration with Bispectral Index Monitoring
时间窗: 24 hours
Deep Hypnotic Time is the period during the Bispectral Index (BIS) are extensively less than 40 (a scale of 0 - 100). The BIS value that is believed to prevent 50% of the population from responding to verbal instructions placed on an index value of 67 - 79. Targeted BIS value to prevent awareness under general anesthesia are at a range of 40 - 60. A study conducted using BIS, shows that under a standard care, BIS value during operative maintenance period tends to be lower which sat around 36 (31 - 49). Duration is the lower the DHT duration the better the outcome of the patient, duration is measured in minutes
次要结局
- Mini Mental State Examination exam before and after operation in both control and experimental group(24 hours)