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Device

HFVI for Pain relief

N/A
Waitlist Available
Led By Jay W Johansen, MD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes; 30 minutes; 45 minutes; 60 minutes
Awards & highlights

Study Summary

This trial will test whether a new technique for administering fentanyl during surgery is safe and effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes; 30 minutes; 45 minutes; 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes; 30 minutes; 45 minutes; 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Numerical Pain Scores (NPS)
Secondary outcome measures
Incidence of postoperative nausea and vomiting (PONV) in the PACU
Number of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU).
Percentage of patients minimal pain (NPS < 3) during recovery

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HFVI intervention groupExperimental Treatment1 Intervention
Subjects in the HFVI intervention group will be monitored in the same manner as the control group, but the HFVI monitor display will also be available to the anesthesia provider in real time. Bolus doses of 25ug or 50 ug of fentanyl will be recommended to be administered when the HFVI values begin to decrease below 50, and as needed based on the judgment of the clinician responsible for the case. All anesthetic medications that are given, patient events, and vital sign recordings will be included in the anesthetic record and data collection forms.
Group II: Standard of Care GroupActive Control1 Intervention
Subjects receiving a balanced maintenance anesthetic consisting primarily of a sevoflurane hypnotic (titrated to a BIS range of 40-60) and fentanyl analgesia. Subjects randomized to the control group (Standard Practice) will have analgesia administered as needed according to standard clinical monitoring and practice requirements based on the judgment of the clinician responsible for the case. The HFVI monitor will be applied, but the display will be masked in this control group population.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HFVI
2020
N/A
~10

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,350 Previous Clinical Trials
719,955 Total Patients Enrolled
Mdoloris Medical SystemsUNKNOWN
Jay W Johansen, MD, PhDPrincipal InvestigatorUniversity of Florida

Media Library

HFVI (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04049656 — N/A
Pain relief Clinical Trial 2023: HFVI Highlights & Side Effects. Trial Name: NCT04049656 — N/A
HFVI (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04049656 — N/A
Pain relief Research Study Groups: Standard of Care Group, HFVI intervention group
~1 spots leftby Jun 2025
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