Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects (NCT04049656) | Clinical Trial Compass
CompletedNot Applicable
Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects
United States5 participantsStarted 2020-10-08
Plain-language 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.
The overall objective of this study is to confirm the safety and efficacy of HFVI-guided analgesic administration in comparison to standard clinical practice. The primary efficacy endpoint will be the amount of postoperative pain reported in the PACU, as measured using a nurse administered Numerical Rating Scale (NRS) pain score.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 u…