NCT04343638

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients Undergoing Total Laparoscopic Hysterectomy

Interventions

Type	Name	Description
DEVICE	conventional nociception control	While Intraoperative opioid will be administered by conventional clinical practice in control arm.
DEVICE	ANI monitor guided nociception control	The intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50 in ANI-monitor guided nociception control arm.

Timeline

• Start date: 2020-05-08
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2020-04-13
• Last updated: 2021-12-29

Locations

1 site across 1 country: South Korea