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The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.
eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.
Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation (5s, 50mA) and intubation. The concentration combinations include the electrical stimulation combination (effector chamber concentration random: remifentanil 0-3 ng/ml, propofol 3-5 ug/ml) and the intubation combination (effector chamber concentration random: remifentanil 3-5 ng/ml, propofol 3-5 ug/ml). All combinations were decided before operation. Every combination had a 5 min equilibration period, and the vital signs (Heart Rate, Blood pressure, any body movement) and BIS, eMAC will be recorded before and after the electrical stimulation and intubation. After this period, patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia, and regular anesthesia is executed. This study only records vital signs and BIS, eMAC during maintenance period of perioperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 BIS under tetanic electrical stimulation | Active Comparator | During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS. |
|
| Group 2 eMAC under tetanic electrical stimulation | Active Comparator | During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC. |
|
| Group 3 BIS under intubation | Active Comparator | During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS. |
|
| Group 4 eMAC under intubation | Active Comparator | During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol (Random:3-5ug/ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prediction probability of eMAC | Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween eMAC and the lable of response was calculated. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction probability of BIS | Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween BIS and the lable of response was calculated. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haopeng Zhang, Dr | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20216387 | Background | Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368. | |
| 23471754 | Background | Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6. |
| Label | URL |
|---|---|
| For PubMed ID: 20216387 | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 26, 2024 | |
| Reset | Oct 24, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 26, 2024 | Oct 24, 2024 |
| ID | Term |
|---|---|
| D015742 | Propofol |
| D007440 | Intubation |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Low Remifentanil | Drug | Remifentanil (Random:0-3ug/ml) |
|
|
| Heigh Remifentanil | Drug | Remifentanil (Random:3-5ug/ml) |
|
|
| Intubation | Procedure | Endotracheal intubation before surgery |
|
| tetanic electrical stimulation | Procedure | tetanic electrical stimulation before surgery |
|
| 19741484 | Background | Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef. |
| 40244902 | Derived | Zhang H, Zhang J, Li X, He S, Deng Z, Wang L, Wang Y, Wang X, Wan C, Huang F, Zhu Z, Dong H. Feasibility Study of an Indicator of Equivalent Potency of Multiple Anesthetics Normalized by Minimum Alveolar Concentration Derived From Response Surface Models. Anesth Analg. 2026 Mar 1;142(3):541-550. doi: 10.1213/ANE.0000000000007514. Epub 2025 Apr 17. |
| For PubMed ID: 19741484 | View source |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |