Status:
COMPLETED
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)
Lead Sponsor:
Medtronic - MITG
Conditions:
Anesthesia
Eligibility:
All Genders
18-60 years
Phase:
NA
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.
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 anes...
Eligibility Criteria
Inclusion
- 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
- 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 \[assessment by PI or delegate\];
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04466384
Start Date
August 11 2020
End Date
March 3 2021
Last Update
July 19 2022
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710