Clinical trial NCT04602546: Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
Official title: Evaluation of BIS™ and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized study to collect data to evaluate the relationship between BIS and inhaled anesthetics
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

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. \[Pre-dose vital signs will be assessed by the Principal Investigator or designee (e.g., a medically qualified sub-investigator) before study drug administration. The Principal Investigator or designee will verify the eligibility of each subject with out-of-range vital signs and document approval before dosing\].

Exclusion Criteria:

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 \[assessment by PI or delegate\].

Primary outcomes:
measure: BIS 50
timeFrame: duration of anesthesia administration, up to 2 hours
Secondary outcomes:
measure: BIS 95
timeFrame: duration of anesthesia administration
measure: Prediction Probability (PK)
timeFrame: duration of anesthesia administration, up to 2 hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center
state: Utah
Study officials:
affiliation: Duke University
name: David MacLeod, MBBS
role: PRINCIPAL_INVESTIGATOR
References: