Patients Undergoing Total Laparoscopic Hysterectomy
Conditions
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.
Interventions
DEVICEconventional nociception control
While Intraoperative opioid will be administered by conventional clinical practice in control arm.
DEVICEANI 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| serum catecholamine (norepinephrine, epinephrine) level | 1 hour after the surgery | Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn 1hour after surgery. |
Countries
South Korea
Outcome results
None listed