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

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ClinicalTrials.gov Identifier: NCT04602546
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: BIS Complete Monitoring System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized study to collect data to evaluate the relationship between BIS and inhaled anesthetics
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of BIS™ and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2022

Arm Intervention/treatment
Active Comparator: Sevoflurane alone

Sevoflurane will be administered in steps to achieve a loss of consciousness via a tight-face mask by increasing the end-tidal concentration of Sevoflurane (ETSEVO). Targeted concentration for ETSEVO are 0.25, 0.5, 0.75, 1, 3, 4, 5% or higher until MOAA/S scales at values less than 2 is reached.

The equilibration time for each targeted concentration will be approximately 12 minutes to maintain a constant ETSEVO. The BIS™ value, MOAA/S score and picture recall test will be assessed when the patient is awake and at the different ETSEVO concentrations.

ETSEVO is decreased by the same steps until consciousness is regained.

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.

Active Comparator: Sevoflurane with Remifentanil Group

Two (2) minutes before starting sevoflurane, to attain an effect-site targeted concentration of remifentanil of 4 ng/ml, an initial IV bolus of remifentanil will be given followed by the start of an infusion. Approximately within 7 minutes, the infusion rate of remifentanil may be adjusted to maintain the effect-site concentration of remifentanil of 4 ng/ml.

Sevoflurane will be administered via a tight-face mask in steps to achieve a loss of consciousness by increasing the end-tidal concentration of Sevoflurane (ETSEVO). Targeted concentration for ETSEVO are 0.25, 0.5, 0.75, 1, 3, 4, 5% or higher until an MOAA/S score of less than 2 is reached.

ETSEVO is decreased by the same steps until consciousness is regained.

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.

Active Comparator: Sevoflurane with Fentanyl Group

Two (2) minutes before starting sevoflurane, to attain an effect-site targeted concentration of fentanyl of 2 ng/mL, an initial IV bolus of fentanyl will be given followed by the start of an infusion. Approximately within 10 minutes, the infusion rate of fentanyl may be adjusted to maintain the effect-site concentration of fentanyl of 2 ng/ml.

Sevoflurane will be administered via a tight-face mask in steps to achieve a loss of consciousness by increasing the end-tidal concentration of Sevoflurane (ETSEVO). Targeted concentration for ETSEVO are 0.25, 0.5, 0.75, 1, 3, 4, 5% or higher until an MOAA/S score of equal to or less than 2 is reached.

ETSEVO is decreased by the same steps until consciousness is regained.

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.

Active Comparator: Desflurane Group

Due to desflurane being a volatile agent and not well tolerated as an induction agent, an initial IV bolus of 1% propofol provided at 2mg/kg, with supplemental boluses given at the investigators discretion in order to achieve LMA insertion, will be administered 15-20 minutes prior to desflurane. Once correct LMA placement has been confirmed, there will be an equilibrium time of approximately 15-20 minutes to allow the effect site concentration of propofol to reach a level consistent with a pharmacodynamic effect of consciousness as measured by a MOAA/S score of 2 or 3. Desflurane will then be administered via a tight-face mask at the targeted end-tidal concentration (ETDES) of 2, 5, 7, 8, 9, 10 %, or higher until an MOAA/S score of less than 2 is reached.

The BIS™ value will be correlated with desflurane ETDES concentration. ETDES is decreased by the same steps until consciousness is regained.

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.

Active Comparator: Isoflurane Group

Due to isoflurane being a volatile agent and not well tolerated as an induction agent, an initial IV bolus of 1% propofol provided at 2mg/kg, with supplemental boluses given at the investigators discretion in order to achieve LMA insertion, will be administered 15-20 minutes prior to isoflurane.Isoflurane will be administered via a tight-face mask in steps to achieve a loss of consciousness (MOAA/S of 0,1) by increasing the end-tidal concentration of Isoflurane (ETISO). Targeted concentration for ETISO are 0.25, 0.5, 0.75, 1, 1.5% or higher until MOAA/S scales at values less than 2 is reached.

The BIS™ value will be correlated with desflurane ETISO concentration. ETISO is decreased by the same steps until consciousness is regained.

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.




Primary Outcome Measures :
  1. BIS 50 [ Time Frame: duration of anesthesia administration ]
    To determine BIS50 (BIS™ value at which 50% of patients will be unresponsive at a given drug concentration)


Secondary Outcome Measures :
  1. BIS 95 [ Time Frame: duration of anesthesia administration ]
    To determine BIS95 (BIS™ value at which 95% of patients will be unresponsive at a given drug concentration)

  2. Prediction Probability (PK) [ Time Frame: duration of anesthesia administration ]
    To determine Prediction Probability (PK) for correctly predicting if the subject was responsive or unresponsive.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 [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].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602546


Contacts
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Contact: Stephanie Monza, BS 3037630813 stephanie.r.monza@medtronic.com
Contact: Stacy Osborn, BS 1-720-503-3073 stacy.osborn@medtronic.com

Locations
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United States, California
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Aimee Arias, BS       aimee.arias@ucsf.edu   
Principal Investigator: Odmara Barreto Chang, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ashley Burke, BS       ashley.burke@duke.edu   
Principal Investigator: David MacLeod, MBBS         
United States, Utah
University of Utah Health Science Center Enrolling by invitation
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: David MacLeod, MBBS Duke University
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT04602546    
Other Study ID Numbers: MDT19053OLIVER
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes