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Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy

NCT04343638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-12-29

No results posted yet for this study

Summary

The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. The ANI monitor calculates HR variation with respiration, a response mediated primarily by changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the heart. The aim of this study is to determine the relation between ANI monitor values and serum catecholamine levels. We will compare the serum catecholamine (norepinephrine, epinephrine) levels of conventional nociception control group and ANI-monitor guided nociception control group at the end of surgery.

Conditions

  • Patients Undergoing Total Laparoscopic Hysterectomy

Interventions

DEVICE

conventional nociception control

While Intraoperative opioid will be administered by conventional clinical practice in control arm.

DEVICE

ANI monitor guided nociception control

The intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50 in ANI-monitor guided nociception control arm.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2021-10-28
Completion
2021-10-28

Countries

  • South Korea

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 NCT04343638 on ClinicalTrials.gov