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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional nociception control arm | Active Comparator | 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 | Experimental | Intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional nociception control | Device | While Intraoperative opioid will be administered by conventional clinical practice in control arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| hormone level (cortisol, adrenocorticotropic hormone) |
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Inclusion Criteria:
1. patients undergoing total laparoscopic hysterectomy under general anesthesia (American society of anesthesiologists classification 1~3)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37601786 | Derived | Kim SH, Chang CH, Lee JR, Seo SK, Kwon YI, Lee JH. Effect of analgesia nociception index monitor-based nociception control on perioperative stress responses during laparoscopic surgery in Trendelenburg position: a randomized controlled trial. Front Med (Lausanne). 2023 Aug 4;10:1196153. doi: 10.3389/fmed.2023.1196153. eCollection 2023. |
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The subject will be randomly allocated to 2 groups using computer-generated randomization method. Anesthesiologists will not be blinded to the groups because of organizational reasons.
| 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. |
|
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 |
| serum catecholamine (norepinephrine, epinephrine) level | Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery. | 1 hour after the surgery |