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The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observation | Patients
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesia Nociception Index, remimazolam | Combination Product | The purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam. During this study, remimazolam infusion rate is determined by the pharmacopoeia. Remifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model. ANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| ANI values | A value indicating the degree of pain calculated by ANI's algorithm | During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate (HR) change | Because the ANI value is calculated using the change in HR, it is measured to correlate the change in ANI value with the change in HR due to pain. | Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation |
| Patient state index (PSI) change |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic change | When there are changes of heart rate or blood pressure more than 20% from baseline within 5 minutes of pain stimulus | within 5 minutes of pain stimulus |
Inclusion Criteria:
Patients
Exclusion Criteria:
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Patients who visit the hospital and undergo surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jungmin Lee | Contact | 821041929159 | jminyi19@gmail.com | |
| Joohyun Lee | Contact | 821074200912 | hightothesky1004@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Joo | Ilsan Cha hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic-Kwandong University, School of Medicine | Recruiting | Incheon | 22711 | South Korea |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
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The PSI is an indicator of a patient's depth of sedation and is calculated based on EEG, which can change in response to painful stimuli. The PSI score is expressed as a number between 0 and 100, and it is usually recommended to maintain under 60 during surgery. An increase in the PSI score can indicates the degree of pain stimulus and can be used as an indicator to assess the validity of the ANI value. |
| Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation |
| Blood Pressure change | When a patient feels pain, it stimulates the autonomic nervous system to change blood pressure. This change is measured to determine how much pain the patient is feeling | Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation |
| Remimazolam infusion rate | Remimazolam is a sedative. The infusion rate of remimazolam correlates with sedation level. And it is measured to determine if sedation level correlates with ANI values when pain stimuli are given. | During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change) |
| Effect site concentration of remifentanil | Remifentanil is an opioid and can affect pain levels when given a pain stimulus. | During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change) |