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

Not Applicable

Completed

• Conditions: Patients Undergoing Total Laparoscopic Hysterectomy
• Interventions: Device: conventional nociception control; Device: ANI monitor guided nociception control

• Registration Number: NCT04343638
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Study Start: 2020-05-08
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional nociception control arm	conventional nociception control	Intraoperative opioid will be administered by conventional clinical practice. ANI monitor readings will not be visible to the anesthesiologist.
ANI-monitor guided nociception control arm	ANI monitor guided nociception control	Intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50.

Primary Outcome Measures

Name	Time	Method
Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery	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 Outcome Measures

Name	Time	Method
hormone level (cortisol, adrenocorticotropic hormone)	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.
plasma inflammatory markers (IL-6, IL-10, HMGB1)	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.
serum catecholamine (norepinephrine, epinephrine) level	1 hour after the surgery	Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of