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Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects

NCT04049656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-01-11

No results posted yet for this study

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.

Conditions

  • Analgesia

Interventions

DEVICE

HFVI

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.

Sponsors & Collaborators

  • Mdoloris Medical Systems

    collaborator UNKNOWN

  • University of Florida

    lead OTHER

Principal Investigators

  • Jay W Johansen, MD, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2024-01-09
Completion
2024-01-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049656 on ClinicalTrials.gov