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

Not Applicable

Completed

• Conditions: Anesthesia

• Registration Number: NCT04602546
• Lead Sponsor: Medtronic - MITG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Study Start: 2021-02-09
• Primary Completion: 2022-08-26
• Study Completion: 2022-08-26
• Results First Submitted: 2023-02-27
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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].

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BIS 50	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).

Secondary Outcome Measures

Name	Time	Method
BIS 95	duration of anesthesia administration	To determine BIS95, 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 95% 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).
Prediction Probability (PK)	duration of anesthesia administration, up to 2 hours	To determine if the value on the BIS™ monitor (index score on a scale of 0-100 (0 being dead and 100 being fully awake/responsive) on the BIS™ monitor) can predict the subject's responsiveness 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).

Trial Locations

Locations (3)

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