Status:
COMPLETED
Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Mdoloris Medical Systems
Conditions:
Analgesia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The current study is intended to be a prospective clinical performance validation study designed to confirm the clinical utility of HFVI-guided fentanyl administration during sevoflurane anesthesia. ...
Detailed Description
HFVi was designed to provide a standardized measure of the parasympathetic component (p∑) of the Autonomous Nervous System (ANS). It tracts changes of the p∑ tonus induced by each respiratory cycle (s...
Eligibility Criteria
Inclusion
- Able to provide informed consent
- American Society of Anesthesiologist Physical Status 1 or 2
- Body Mass Index range of 19-35 kg.m-2.
- Planned spinal or open abdominal surgery expected to last 1-3 hours utilizing a balanced sevoflurane-fentanyl general anesthetic
Exclusion
- Subjects are unable or unwilling to give informed consent.
- Emergency surgery
- Women who are currently pregnant or not using a medically acceptable means of birth control
- Cardiac morbidity, including non-regular sinus cardiac rhythm or implanted cardiac pacemaker
- Concurrent medications with a major effect upon the sinus node including prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, and antiarrhythmic agents
- Expected duration of surgery less than 1 hour (60 minutes) or greater than 3 hours (180 minutes)
- Pre-operative chronic opioid use or chronic pain, equivalent to requiring oxycodone 20mg per oral, per day for more than 6 weeks
- Allergy or intolerance to any of the anticipated study medications, such as history of malignant hyperthermia during anesthesia
- Planned use of neuraxial anesthesia
- Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04049656
Start Date
October 8 2020
End Date
January 9 2024
Last Update
January 11 2024
Active Locations (1)
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1
UF Health Jacksonville
Jacksonville, Florida, United States, 32209