Evaluation of BIS™ and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
a study on Anesthesia
Summary
- Eligibility
- for people ages 18-60 (full criteria)
- Healthy Volunteers
- healthy people welcome
- Location
- at UCSF
- Dates
- study startedestimated completion
- Principal Investigator
- by Odmara Barreto Chang (ucsf)
Description
Summary
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.
Keywords
Anesthesia BIS Complete Monitoring System Sevoflurane alone
Eligibility
You can join if…
Open to people ages 18-60
- 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: 50-90. 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 CAN'T join if...
- 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 [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].
Locations
- University of California at San Francisco
accepting new patients
San Francisco California 94143 United States - University of Utah Health Science Center
accepting new patients by invitation only
Salt Lake City Utah 84132 United States
Lead Scientist at University of California Health
- Odmara Barreto Chang (ucsf)
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Medtronic - MITG
- ID
- NCT04602546
- Study Type
- Interventional
- Participants
- Expecting 150 study participants
- Last Updated