ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia

March 15, 2024 updated by: Tiffany B Moon, University of Texas Southwestern Medical Center

A Prospective, Randomized, PACU Blinded Study to Compare ANI-guided Analgesic Administration Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia

This study aims to be a randomized, controlled study of ANI-guided opioid administration versus standard clinical practice in surgical patients undergoing general anesthesia with balanced sevoflurane-fentanyl. Patients will be randomly assigned to 2 groups- ANI vs. standard care. The intraoperative and postoperative management of all patients will be standardized by protocol. The PACU nurses and postop assessor will be blinded as to which group the patient is in.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Health & Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-75 years old
  • ASA 1-2
  • BMI 19-35 kg/m2
  • Patients undergoing surgery with general anesthesia with sevoflurane- fentanyl
  • Planned abdominal or spinal surgery lasting 1-3 hours
  • Willing and able to consent in English or Spanish
  • No current history of advanced pulmonary or cardiovascular disease

Exclusion Criteria:

  • Age less than 18 or older than 75
  • Patient does not speak English or Spanish
  • Patient refusal
  • Monitored anesthesia care (MAC) or regional anesthesia planned
  • Pregnant or nursing women
  • "Stat" (emergent) cases
  • ECG rhythm other than regular sinus rhythm
  • Implanted pacemakers
  • On antimuscarinic agents, alpha 2 agonists, antiarrhythmics, or beta blockers
  • Presence of pacemaker
  • Autonomic nervous system disorder
  • Use of chronic opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard opioid administration
Intraoperative opioid will be administered by guiding standard practice
Other: Standard opioid administration
Intraoperative opioid will be administered according to standard practice during surgery.
Experimental: ANI-guided opioid administration
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
Device: ANI-guided opioid administration
Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of severe postoperative pain
Time Frame: postoperative recovery period
The primary outcome will be the NRS pain scores reported during recovery
postoperative recovery period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of pain medication use
Time Frame: Perioperative and postoperative recovery period
The total amounts of opioid analgesics administered in the operating room (OR) and post-anesthesia care unit (PACU)
Perioperative and postoperative recovery period
The incidence of postoperative nausea/vomiting in post-anesthesia care unit (PACU)
Time Frame: Postoperative recovery period
The incidence of nausea/vomiting reported during recovery
Postoperative recovery period
The incidence of minimal pain
Time Frame: Postoperative recovery period
The percent of subjects with minimal pain (NPS < 3) in post-anesthesia care unit (PACU)
Postoperative recovery period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Tiffany Moon, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2019

Primary Completion (Actual)

March 6, 2023

Study Completion (Actual)

March 6, 2023

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2018-0096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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