- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04466384
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA) (SONORA)
July 5, 2022 updated by: Medtronic - MITG
The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.
Study Overview
Detailed Description
This is a single-center, prospective, non-randomized, cross-over study to collect data to evaluate the relationship between BIS™ and anesthetic regimens.
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 (P) or Propofol with 4 ng/ml of Remifentanil (R) regimens while BIS™ bilateral sensor placed on the subject's forehead.
The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale, refer to Appendix A, will be used to measure the level of alertness in sedated subjects with Tetanic Electrical Stimulation (TES) being used once subjects reach a MOAA/S score <2.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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];
Exclusion Criteria:
- 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];
- The subject must not take any prescription medication, except female hormonal contraceptives or hormone replacement therapy, from 146 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Propofol
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.
|
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.
|
OTHER: Propofol with Remifentanil
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BIS50
Time Frame: 4 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BIS95
Time Frame: 4 hours
|
To determine BIS95 (BIS™ value at which 95% 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 BIS95.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 11, 2020
Primary Completion (ACTUAL)
March 3, 2021
Study Completion (ACTUAL)
March 3, 2021
Study Registration Dates
First Submitted
July 7, 2020
First Submitted That Met QC Criteria
July 7, 2020
First Posted (ACTUAL)
July 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 19, 2022
Last Update Submitted That Met QC Criteria
July 5, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- MDT19049SONORA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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