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

NCT ID: NCT04343638

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-08

Study Completion Date

2021-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Patients Undergoing Total Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The subject will be randomly allocated to 2 groups using computer-generated randomization method. Anesthesiologists will not be blinded to the groups because of organizational reasons.

Study Groups

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conventional nociception control arm

Intraoperative opioid will be administered by conventional clinical practice. ANI monitor readings will not be visible to the anesthesiologist.

Group Type ACTIVE_COMPARATOR

conventional nociception control

Intervention Type DEVICE

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

ANI-monitor guided nociception control arm

Intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50.

Group Type EXPERIMENTAL

ANI monitor guided nociception control

Intervention Type DEVICE

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

Interventions

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conventional nociception control

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\. patients undergoing total laparoscopic hysterectomy under general anesthesia (American society of anesthesiologists classification 1\~3)

Exclusion Criteria

1. endometriosis
2. AP diameter of uterus \> 12cm
3. cognitive disorder
4. arrhythmia, pacemaker
5. chronic opioid use
6. diseases affecting autoimmune system (immune disease, diabetic neuropathy)
7. use of medications affecting ANI monitor (antimuscarinics, alpha-agonist, beta blocker)
8. illiteracy, foreigner
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim SH, Chang CH, Lee JR, Seo SK, Kwon YI, Lee JH. Effect of analgesia nociception index monitor-based nociception control on perioperative stress responses during laparoscopic surgery in Trendelenburg position: a randomized controlled trial. Front Med (Lausanne). 2023 Aug 4;10:1196153. doi: 10.3389/fmed.2023.1196153. eCollection 2023.

Reference Type DERIVED
PMID: 37601786 (View on PubMed)

Other Identifiers

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4-2020-0130

Identifier Type: -

Identifier Source: org_study_id