Evaluation of BIS™ and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)

Medtronic - MITG3 个研究点分布在 1 个国家目标入组 211 人开始时间: 2021年2月9日最近更新: 2023年4月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Medtronic - MITG
入组人数: 211
试验地点: 3
主要终点: BIS 50

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states, and to provide evidence to support BIS™ performance in use with Isoflurane, Sevoflurane and Desflurane in combination with opioids.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy (ASA physical status 1), male or female subjects between the ages of 18 to 60 years;
•Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
•Vital signs must be within the following ranges to be included: Vital signs measured sitting after 3 minutes rest; heart rate: 45-90 bpm; systolic blood pressure: 110-140; diastolic blood pressure: 50-
•Out-of-range vital signs may be repeated once. [Pre-dose vital signs will be assessed by the Principal Investigator or designee (e.g., a medically qualified sub-investigator) before study drug administration. The Principal Investigator or designee will verify the eligibility of each subject with out-of-range vital signs and document approval before dosing].

排除标准

•Has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes, or other medical sensors [self-reported];
•Known neurological disorder (e.g., epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma) [self-reported and assessment by PI or delegate];
•Known cardiovascular disease (e.g., hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving a decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/ pacemaker/ automatic internal cardioverter defibrillator), current implanted pacemaker or automatic internal cardioverter defibrillator [self-reported and assessment by PI or delegate];
•Has a clinically significant abnormal finding on medical history, physical examination, clinical laboratory tests, or ECG at the screening [self-reported and assessment by PI or delegate];
•Use of psychoactive medication within the past 60 days (e.g., benzodiazepines, antiepileptic drugs, Parkinson's medication, anti-depressant drugs, opioids) [self-reported and assessment by PI or delegate];
•Subjects with known gastric diseases [self-reported and assessment by PI or delegate];
•Has a positive urine cotinine test or urine drug screen or oral ethanol test [Point of Care (POC) testing];
•Known history of allergic or adverse response to drugs to be administered [self-reported];
•Known history of complications relating to previous general anesthesia or conscious sedation [self-reported and assessment by PI or delegate];
•Known history of malignant hyperthermia [self-reported and assessment by PI or delegate];
•Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate];
•Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate];
•Pregnant or lactating women [assessed by urine test and self-reported];
•Subjects with tattooed skin specific to the sensor placement areas (forehead, fingers, chest) [self-reported and assessment by PI or delegate];
•The subject must not take any prescription medication, except female hormonal contraceptives or hormone replacement therapy, from 14 days before the dosing until the end-of-study visit without evaluation and approval by the Investigator. Subjects who participated in a previous clinical trial who received a required FDA approved concomitant medication, for example, naltrexone, but were not randomized may be considered for participation in this study if they meet the washout requirement [assessment by PI or delegate].

研究组 & 干预措施

Sevoflurane alone

Active Comparator

Sevoflurane will be administered in steps to achieve a loss of consciousness via a tight-face mask by increasing the end-tidal concentration of Sevoflurane (ETSEVO). Targeted concentration for ETSEVO are 0.25, 0.5, 0.75, 1, 3, 4, 5% or higher until MOAA/S scales at values less than 2 is reached.

The equilibration time for each targeted concentration will be approximately 12 minutes to maintain a constant ETSEVO. The BIS™ value, MOAA/S score and picture recall test will be assessed when the patient is awake and at the different ETSEVO concentrations.

ETSEVO is decreased by the same steps until consciousness is regained.