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

Anesthesia Clinical Trial

— OLIVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602546
• Other study ID #: MDT19053OLIVER
• Status: Completed
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: March 2023
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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].

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• BIS Complete Monitoring System
The BIS™ EEG complete monitoring system is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The system and its associated parameters are intended for use on adult patients within a hospital or medical facility, providing patient care to monitor the state of the brain by data acquisition of EEG signals.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Utah Health Science Center	Salt Lake City	Utah
United States	University of California at San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS 50	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).	duration of anesthesia administration, up to 2 hours
Secondary	BIS 95	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).	duration of anesthesia administration
Secondary	Prediction Probability (PK)	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).	duration of anesthesia administration, up to 2 hours