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

Completed · Not applicable

Conditions studied: Anesthesia

In brief

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.

Key facts

Study ID

NCT04602546

Run by

Medtronic - MITG

People needed

211

Starts

2021-02-09

Expected to finish

2022-08-26

Last updated by the study team

2023-04-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 may not qualify 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 [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].

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Utah Health Science Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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