NCT04602546已完成不适用
Evaluation of BIS™ and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 6
- 主要终点
- BIS 50
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].
结局指标
主要结局
BIS 50
时间窗: duration of anesthesia administration, up to 2 hours
To determine BIS50, the BIS™ value (index score on a scale of 0-100 (0 being dead and 100 being fully awake/responsive) on the BIS™ monitor) at which 50% of patients will be unresponsive at a given drug concentration. Responsiveness is measured using the Modified Observer's Assessment of Alertness and Sedation (MOAAS) a 0-5 scale where 0 represents no response to deep stimulus and 5 represents fully awake).
次要结局
- BIS 95(duration of anesthesia administration)
- Prediction Probability (PK)(duration of anesthesia administration, up to 2 hours)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric PatientsAnesthesiaNCT04810481Medtronic - MITG209
已完成
不适用
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)AnesthesiaNCT04466384Medtronic - MITG34
招募中
不适用
Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma PatientsTraumatic Brain InjuryNCT06311604University Hospital, Grenoble30
已完成
不适用
Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled TrialColonoscopyNCT03453359Hospital Galdakao-Usansolo180
撤回
不适用
Feasibility of Using Depth-of-sedation Measuring Equipment (BIS) to Guide Awake Fibreoptic IntubationKnown Difficult IntubationNCT01207154Oxford University Hospitals NHS Trust