CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
ANI-guided opioid administration +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03684590
NCT03684590N/ACompleted
CompareCT.gov

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

University of Texas Southwestern Medical Center·interventional·Posted Sep 25, 2018·Updated Apr 30, 2025

In Brief

A clinical study evaluating ANI-guided opioid administration and Standard opioid administration for Acute Pain. Completed, enrolled 102 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 25, 2018
Enrollment StartJul 30, 2019
Primary CompletionMar 6, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.8 years ago

Interventions

ANI-guided opioid administrationdevice

Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)

Standard opioid administrationother

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