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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT04343638

Collaborator

(none)

Enrollment

Location

Arms

17.7

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patients Undergoing Total Laparoscopic Hysterectomy	Device: conventional nociception control Device: ANI monitor guided nociception control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 8, 2020

Actual Primary Completion Date :

Oct 28, 2021

Actual Study Completion Date :

Oct 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: conventional nociception control arm Intraoperative opioid will be administered by conventional clinical practice. ANI monitor readings will not be visible to the anesthesiologist.	Device: conventional nociception control While Intraoperative opioid will be administered by conventional clinical practice in control arm.
Experimental: ANI-monitor guided nociception control arm Intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50.	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.

Arm

Intervention/Treatment

Active Comparator: conventional nociception control arm

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

Device: conventional nociception control

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

Experimental: ANI-monitor guided nociception control arm

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

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.

Outcome Measures

Primary Outcome Measures

Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery [at the end of surgery (skin closure)]
Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn at the end of surgery and 1 hour after the end of surgery..

Secondary Outcome Measures

plasma inflammatory markers (IL-6, IL-10, HMGB1) [at the end of surgery (skin closure) and 1 hour after the end of surgery]
Blood samples for plasma inflammatory markers (IL-6, IL-10, HMGB1) will be drawn at the end of surgery (skin closure) and 1 hour after the end of surgery.
hormone level (cortisol, adrenocorticotropic hormone) [at the end of surgery (skin closure) and 1 hour after the end of surgery]
blood samples for hormone levels (cortisol, adrenocorticotropic hormone) will be drawn at the end of surgery (skin closure) and 1 hour after the end of surgery.
serum catecholamine (norepinephrine, epinephrine) level [1 hour after the surgery]
Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

endometriosis
AP diameter of uterus > 12cm
cognitive disorder
arrhythmia, pacemaker
chronic opioid use
diseases affecting autoimmune system (immune disease, diabetic neuropathy)
use of medications affecting ANI monitor (antimuscarinics, alpha-agonist, beta blocker)
illiteracy, foreigner

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04343638

Other Study ID Numbers:

4-2020-0130

First Posted:

Apr 13, 2020

Last Update Posted:

Dec 29, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 29, 2021