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

Yonsei University72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Patients Undergoing Total Laparoscopic Hysterectomy

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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..

Time frame: at the end of surgery (skin closure)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 1 hour after the surgery