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HFVI for Pain relief

Q: Is it possible for me to partake in this medical research experiment?

This medical experiment is currently enrolling 104 individuals aged between 18 and 75 that suffer from analgesia. The team also requires participants to have a BMI of 19-35 kg/m2 for eligibility.

Q: Does the study acknowledge geriatric patients as potential participants?

Recruitment for this experiment is open to any individual who has attained the age of majority and does not exceed 75 years old.

Q: Is the recruitment period for this experiment still open?

Per the clinicaltrials.gov page, this experiment has stopped recruiting patients as of November 28th 2022; its initial post date was October 8th 2020. Despite this trial's closure for recruitment, an additional 108 medical trials are still looking to enrol participants at present.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes; 30 minutes; 45 minutes; 60 minutes

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,700 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to partake in this medical research experiment?

"This medical experiment is currently enrolling 104 individuals aged between 18 and 75 that suffer from analgesia. The team also requires participants to have a BMI of 19-35 kg/m2 for eligibility."

Answered by AI

Does the study acknowledge geriatric patients as potential participants?

"Recruitment for this experiment is open to any individual who has attained the age of majority and does not exceed 75 years old."

Answered by AI

Is the recruitment period for this experiment still open?

"Per the clinicaltrials.gov page, this experiment has stopped recruiting patients as of November 28th 2022; its initial post date was October 8th 2020. Despite this trial's closure for recruitment, an additional 108 medical trials are still looking to enrol participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects

2020. "Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04049656.