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

Yonsei University

Status: Completed

Conditions: Patients Undergoing Total Laparoscopic Hysterectomy

Treatments: Device: conventional nociception control; Device: ANI monitor guided nociception control

Study type: Interventional

Funder types: Other

Identifiers

NCT04343638

4-2020-0130

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

conventional nociception control arm

Active Comparator group

Description:

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

Treatment:

Device: conventional nociception control

ANI-monitor guided nociception control arm

Experimental group

Description:

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

Treatment:

Device: ANI monitor guided nociception control