Completed

NCT Number: NCT04343638

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

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.

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Key information

Conditions

Patients Undergoing Total Laparoscopic Hysterectomy

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional nociception control

Device

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

ANI monitor guided nociception control

Device

The intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50 in ANI-monitor guided nociception control arm.

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

plasma inflammatory markers (IL-6, IL-10, HMGB1)

Time frame: 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)

Time frame: 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

Time frame: 1 hour after the surgery

Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Apr 13, 2020
Registry last updated: Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.