Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)

NCT04466384 | Completed Results FDA Device

• 1 other identifier: MDT19049SONORA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• BIS50

  To determine BIS50 (BIS™ value at which 50% of patients will be unresponsive at given drug concentrations) and other dose-response parameters. BIS™ is a scale 0-100 with values near 100 represent an "awake" clinical state while 0 denotes the maximal EEG effect possible (i.e., an isoelectric EEG). Responsiveness is measured using the Modified Observer's Assessment of Alertness/ Sedation (MOAA/S). Below a MOAA/S of 2, responsiveness is measured with Tetanic Electrical Stimulation (TES). The subject will receive one stimulation of 50mA, 50 Hz for 5 seconds. Their response, such as withdrawal of the extremity, a facial grimace, or a verbal groan will be recorded. Approximately 2 minutes after this assessment, the BIS™ value will be recorded. When the subject does not respond to the TES stimulation, they will be considered unresponsive and that BIS™ value will be used to determine the BIS50.

  4 hours

Secondary Outcomes (1)

• BIS95

  4 hours

Study Arms (2)

Propofol

OTHER

Subjects will be sequentially assigned to start with propofol or propofol with remifentanil. Propofol will be started at a concentration of 0.5 µg/ml followed by incremental increases in the target effect-site concentrations of 1.5, 2, 2.5, 3, 4, 6, and 8 µg/ml until a MOAA/S score less than 2 is reached.

Device: BIS

Propofol with Remifentanil

OTHER

Subjects will be sequentially assigned to start with propofol or propofol with remifentanil. Approximately 2 minutes before starting propofol, to attain an effect-site targeted concentration of remifentanil of 4 ng/ml, remifentanil will be given by a continuous infusion. Within approximately 7 minutes, the infusion rate of Remifentanil may be adjusted to maintain the effect-site concentration of remifentanil of 4 ng/ml throughout the study.

Device: BIS

Interventions

BIS DEVICE

Subjects will be sequentially assigned to the propofol or propofol and remifentanil group. The purpose is to capture the BIS value in association with these anesthetics.

Propofol; Propofol with Remifentanil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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 \[self-reported and assessment by PI or delegate\];
• Recent use of psychoactive medication (e.g., benzodiazepines, antiepileptic drugs, ADHD medication, 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 \[POC testing\];
• 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 ECG \[assessment by PI or delegate\];
• 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) \[self-reported and assessment by PI or delegate\];

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Limitations and Caveats

While there are known risks with providing general anesthesia to adults, this study was deemed to be a non-significant risk study.

Results Point of Contact

• Title: Ami Stuart PhD
• Organization: Medtronic

ami.stuart@medtronic.com

8017934800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The subjects will receive two regimens of anesthesia with different drug combinations, with at least a 1-week washout period between regimens. Subjects will be sequentially assigned to start with either propofol or propofol with remifentanil regiments.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: August 11, 2020
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: July 19, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)