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

Patients Undergoing Total Laparoscopic Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343638
• Other study ID #: 4-2020-0130
• Status: Completed
• Phase: N/A
• Start date: May 8, 2020
• Est. completion date: October 28, 2021

Study information

• Verified date: December 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Total Laparoscopic Hysterectomy

Intervention

Device:
• conventional nociception control
While Intraoperative opioid will be administered by conventional clinical practice in control arm.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	at the end of surgery (skin closure)
Secondary	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.	at the end of surgery (skin closure) and 1 hour after the end of surgery
Secondary	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.	at the end of surgery (skin closure) and 1 hour after the end of surgery
Secondary	serum catecholamine (norepinephrine, epinephrine) level	Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery.	1 hour after the surgery