Using Brain Function Monitors to Guide Anesthetic Management in Improving Anesthesia Recovery: a Randomized Pilot Study to Compare Outcomes in Young Adult Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Speed of Recovery Time
研究概览
简要总结
The purpose of this research is to gather information on the effectiveness of the Sedline Brain Function Monitor, and its use in this study to determine whether monitoring the brain activity during anesthesia will improve recovery, including earlier discharge and less side effects. Furthermore, the study team wants to determine whether males and females respond to anesthetics in a similar manner with and without brain monitoring.
详细描述
While brain function monitoring has been shown to help guide optimal anesthetic dosing and improve recovery in the elderly and young children, its benefits in young adults are not well defined. We hypothesize that brain monitor-guided anesthetic management would decrease post-anesthesia recovery time and improve postoperative experience in this younger group.
This prospective, randomized, single-blinded study at the University of Chicago Medical Center, will enroll adult approximately 100 evaluable patients aged 18-45 years, with ASA physical status I-III, undergoing a scheduled elective surgery, with an anticipated 60-240 minute duration, and receiving general anesthesia. Exclusion criteria includes ASA IV-VI, allergy to anesthetic agents, history of seizures, emergency surgery, procedures precluding SedLine electrode placement, use of gender affirming hormonal therapy, and refusal to participate.
Participants are randomized using gender-stratified block randomization with variable block sizes (4 and 6) generated by an independent biostatistician. Participants and PACU nurses are blinded to group allocation. The anesthesia providers are not blinded due to the nature of the intervention. Postoperative survey interviewers are not blinded.
A member of the research team will use the surgery schedule to identify patients meeting initial study screening criteria. Patients identified as meeting criteria will be approached and study details will be discussed, and after being given time to ask questions, informed consent will be obtained.
The anesthesa care team (i.e., anesthesia providers, etc.) will receive instructions regarding interventional-arms anesthesia administration (i.e., chemical, gas, monitoring, etc.) to use in association with standard of care.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology Physical Status Classification Grade of 1(normal, healthy patient) to Grade 3 (patient with severe disease)
- •Between ages 18-45 years old
- •Planned surgery duration between 60-240 minutes General-endotracheal-tube-anesthesia or general anesthesia with laryngeal mask airway
- •Subjects capable of giving informed consent or
- •Subjects who have an acceptable surrogate capable of giving consent on behalf of the subject
- •All contraception methods will be allowable for any subject in this study. Participants may opt-out of a pregnancy test if they would prefer to proceed with surgery without one.
- •Pregnant women will not be strictly excluded from this study if they meet all other criteria.
排除标准
- •American Society of Anesthesiology Physical Status Classification Grade of 4,5,6 (diseases that are life threatening or no possibility of survival)
- •Listed allergies to any commonly used anesthetic agents
- •History of seizures, as a seizure while using brain monitoring may influence the anesthesia provider in a way that is not aligned with the purpose of this study
- •Any patient undergoing emergency surgery, as can not be ensured that consent will be able to be properly obtained
- •Patient refusal to participate in study
- •Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp)
- •Patients who receive neuraxial anesthesia or a peripheral nerve block as part of their anesthetic
- •Patients who are taking gender-affirming hormonal medications, as this can affect the response to anesthetics
- •The duration of surgery scheduled <60 minutes
研究组 & 干预措施
Control Arm
Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.
Sedline Monitor Arm
Anesthesia care guided by Sedline brain function monitor during the procedure.
干预措施: Sedline Brain Function Monitor (Device)
结局指标
主要结局
Speed of Recovery Time
时间窗: Up to 3 hours
The primary endpoint is the speed of recovery time, measured from the end time of the surgery, to the time of meeting the criteria for pediatric acute care unit (PACU) discharge. These criteria are lack of nausea/vomiting, grogginess and the level of pain; with 0 being no pain and 10 being severe pain.
次要结局
- Patient Rated - PostOperative Pain and Anesthesia Experience(Up to 1 day post surgery)
- Gender-Stratified, PostOperative Care Unit (PACU) Discharge Length of Stay Rate (Minutes) Between Sedline Brain Monitoring-Arm vs Control-Arm(Up to 2 days post surgery)