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Clinical Trials/NCT04343638
NCT04343638
Completed
Not Applicable

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

Yonsei University1 site in 1 country72 target enrollmentMay 8, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Undergoing Total Laparoscopic Hysterectomy
Sponsor
Yonsei University
Enrollment
72
Locations
1
Primary Endpoint
Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2020
End Date
October 28, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery

Time Frame: 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 Outcomes

  • hormone level (cortisol, adrenocorticotropic hormone)(at the end of surgery (skin closure) and 1 hour after the end of surgery)
  • plasma inflammatory markers (IL-6, IL-10, HMGB1)(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)

Study Sites (1)

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