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

NCT03684590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-04-30

Study results available
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Summary

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.

Conditions

  • Acute Pain

Interventions

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)

OTHER

Standard opioid administration

Intraoperative opioid will be administered according to standard practice during surgery.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Tiffany Moon, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2023-03-06
Completion
2023-03-06
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 NCT03684590 on ClinicalTrials.gov