Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic - MITG
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Healthy (ASA physical status 1), male or female subjects between the ages of 18 to 60 years;
2. Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
3. 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: 50-90. Out-of-range vital signs may be repeated once. \[Pre-dose vital signs will be assessed by the Principal Investigator or designee (e.g., a medically qualified sub-investigator) before study drug administration. The Principal Investigator or designee will verify the eligibility of each subject with out-of-range vital signs and document approval before dosing\].
You may not be if
1. 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 \[self-reported\];
2. 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) \[self-reported and assessment by PI or delegate\];
3. 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 \[self-reported and assessment by PI or delegate\];
4. Has a clinically significant abnormal finding on medical history, physical examination, clinical laboratory tests, or ECG at the screening \[self-reported and assessment by PI or delegate\];
5. Use of psychoactive medication within the past 60 days (e.g., benzodiazepines, antiepileptic drugs, Parkinson's medication, anti-depressant drugs, opioids) \[self-reported and assessment by PI or delegate\];
6. Subjects with known gastric diseases \[self-reported and assessment by PI or delegate\];
7. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\];
8. Known history of allergic or adverse response to drugs to be administered \[self-reported\];
9. Known history of complications relating to previous general anesthesia or conscious sedation \[self-reported and assessment by PI or delegate\];
10. Known history of malignant hyperthermia \[self-reported and assessment by PI or delegate\];
11. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\];
12. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
13. Pregnant or lactating women \[assessed by urine test and self-reported\];
14. Subjects with tattooed skin specific to the sensor placement areas (forehead, fingers, chest) \[self-reported and assessment by PI or delegate\];
15. 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 \[assessment by PI or delegate\].
Clareo Health | Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
