A Prospective, Blinded, Clinical Study for Assessing the Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia (DOA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Prediction probability Pk for the WAVcns for consciousness vs unconsciousness
研究概览
简要总结
The objective of this clinical study is to investigate whether the NeuroSENSE is an adequate monitor of hypnotic depth-of-anesthesia (DOA). Therefore, this study will investigate whether the information provided by the NeuroSENSE Monitor can help in assessing the hypnotic effect of anesthetics in adult patients undergoing general anesthesia.
详细描述
In particular, the study will focus on the correlation between the WAVcns index, a proprietary quantifier of cortical activity displayed by the NeuroSENSE, with (1) commonly assessed clinical endpoints/variables relating to the DOA, (2) changes in anesthetic drug administration, and (3) the anesthesiologist's assessment of the DOA based on standard of care monitors and his/her own observations of the patient state.
The hypothesis under evaluation is that the WAVcns index is an independent assessor of the progression of the anesthetic state and events of general anesthesia related to hypnotic endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years
- •ASA (American Society of Anesthesiologist) physical status I, II, or III
- •ability to read and understand the informed consent form
- •undergoing anesthesia procedure requiring intubation
- •scheduled to undergo either open or laparoscopic abdominal surgical procedures (e.g. colectomy, hysterectomy, radical retropubic prostatectomy, nephrectomy, pancreatectomy, etc.), breast surgery including reduction, reconstruction and mastectomies, or orthopedic surgeries under general anesthesia, expected to last at least 1 hour.
排除标准
- •history of major head injury (possible abnormal EEG)
- •acquired scalp or skull abnormalities (e.g. psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants)
- •evidence of recent trauma or active neurological disorder, stroke, seizure disorder, intellectual disability, dementia or diagnosis of Alzheimer's disease
- •major antipsychotic medications taken within last 7 days (eg. Lithium, risperidone, olanzapine)
- •known history of alcohol or drug abuse within last 30 days
- •body mass index (weight in kilograms divided by square of height in meters) > 40.0 kg/m2
- •uncontrolled hypertension with blood pressure recorded prior to surgery (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg)
- •systolic blood pressure < 90 mmHg, recorded prior to surgery
- •heart rate (HR) < 45 beats/min, recorded prior to surgery
- •insulin-dependent diabetes mellitus
- •pregnancy
- •any serious medical condition that would interfere with cardiovascular response assessment or study results interpretation
研究组 & 干预措施
Anesthesia
A single study group undergoing general anesthesia procedure to observe post-hoc the effect on the NeuroSENSE monitor readings.
Interventions of interest:
Drug: Propofol induction followed by randomized doses of desflurane; Emergence by stepping down the desflurane ET - See intervention descriptions.
Device: Recording of EEG using NeuroSENSE (blinded to clinicians) - See intervention descriptions.
Other: Data Collection - See intervention descriptions
干预措施: Propofol induction followed by randomized doses of desflurane (Drug)
Anesthesia
A single study group undergoing general anesthesia procedure to observe post-hoc the effect on the NeuroSENSE monitor readings.
Interventions of interest:
Drug: Propofol induction followed by randomized doses of desflurane; Emergence by stepping down the desflurane ET - See intervention descriptions.
Device: Recording of EEG using NeuroSENSE (blinded to clinicians) - See intervention descriptions.
Other: Data Collection - See intervention descriptions
干预措施: Recording of EEG using NeuroSENSE (Device)
Anesthesia
A single study group undergoing general anesthesia procedure to observe post-hoc the effect on the NeuroSENSE monitor readings.
Interventions of interest:
Drug: Propofol induction followed by randomized doses of desflurane; Emergence by stepping down the desflurane ET - See intervention descriptions.
Device: Recording of EEG using NeuroSENSE (blinded to clinicians) - See intervention descriptions.
Other: Data Collection - See intervention descriptions
干预措施: Data collection (Other)
结局指标
主要结局
Prediction probability Pk for the WAVcns for consciousness vs unconsciousness
时间窗: During induction of anesthesia, an expected average of 4 min
The primary outcome will test the performance of WAVcns index in discriminating between consciousness and unconsciousness during induction of anesthesia. It will be evaluated using Receiver-Operating Characteristic (ROC), and Area Under Curve (AUC) will be calculated. Note that the AUC statistic is equal to the prediction probability Pk for dichotomous responses, such as consciousness and unconsciousness.
次要结局
- Prediction probability Pk for the WAVcns for responders vs nonresponders to lidocaine aerosol(During induction of anesthesia, an expected average of 4 min)
- Correlation of the WAVcns with primary anesthetic dosing(During anesthesia maintenance, an expected average of 2 hrs)
- Prediction probability for the WAVcns for responders vs nonresponders to verbal command(During emergence from anesthesia, an expected average of 20 min)