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

Study Overview
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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.

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

Conditions
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Patients Undergoing Total Laparoscopic Hysterectomy

Intervention / Treatment
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* Device: conventional nociception control
* Device: ANI monitor guided nociception control


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery | Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn at the end of surgery and 1 hour after the end of surgery.. | at the end of surgery (skin closure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma inflammatory markers (IL-6, IL-10, HMGB1) | 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. | at the end of surgery (skin closure) and 1 hour after the end of surgery | 
| hormone level (cortisol, adrenocorticotropic hormone) | 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. | at the end of surgery (skin closure) and 1 hour after the end of surgery | 
| serum catecholamine (norepinephrine, epinephrine) level | Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery. | 1 hour after the surgery |