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The aim of this study is to compare the bispectral index (BIS) and patient state index (PSI) during general anesthesia using remimazolam. The infusion rate of remimazolam is 6-12mg/kg/h during induction of anesthesia and 1-2mg/kg/h during maintenance of anesthesia. To calculate the fraction, the sum of times when BIS<60 and PSI <50 will be divided by the time from the loss of consciousness during induction of anesthesia to fully awake during emergence. We will compare the fraction of BIS <60 and the fraction of PSI <50 to find if there is some difference between the two depth of anesthesia monitoring devices during remimazolam anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam anesthesia | General anesthesia will be induced and maintained by remimazolam and the depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bispectral index and Patient state index monitoring | Device | The depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of time when bispectral index (BIS) was < 60 | The percentage of time when BIS was < 60 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.) | During anesthesia (up to 6hours) |
| The percentage of time when patient state index (PSI) was < 50 | The percentage of time when PSI was < 50 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.) | During anesthesia (up to 6hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate (bpm) | Heart rate (bpm) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit. | During anesthesia (up to 6hours) |
| blood pressure (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients (ASA class I,II) who need general anesthesia for surger
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young-Eun Jang, MD,PhD | Contact | 082-010-9487-2233 | na0ag2@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee-Soo Kim, MD,PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33965206 | Background | Sneyd JR, Gambus PL, Rigby-Jones AE. Current status of perioperative hypnotics, role of benzodiazepines, and the case for remimazolam: a narrative review. Br J Anaesth. 2021 Jul;127(1):41-55. doi: 10.1016/j.bja.2021.03.028. Epub 2021 May 6. | |
| 32157465 | Background | Masui K. Remimazolam besilate, a benzodiazepine, has been approved for general anesthesia!! J Anesth. 2020 Aug;34(4):479-482. doi: 10.1007/s00540-020-02755-1. Epub 2020 Mar 10. No abstract available. |
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blood pressure (mmHg) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit.
| During anesthesia (up to 6hours) |
| Bispectral index (BIS) during anesthesia | Bispectral index (BIS) is continuously recorded during anesthesia. | During anesthesia (up to 6hours) |
| Patient state index (PSI) during anesthesia | Patient state index (PSI) is continuously recorded during anesthesia. | During anesthesia (up to 6hours) |
| The percentage of time when bispectral index (BIS) was < 60, and > 40. | The percentage of time when BIS was < 60, and > 40 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.) | During anesthesia (up to 6hours) |
| The percentage of time when patient state index (PSI) was < 50, and > 25. | The percentage of time when PSI was < 50, and > 25 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.) | During anesthesia (up to 6hours) |
| The last number patient remember that he/she spoke during induction of anesthesia | The last number patient remember that he/she spoke during induction of anesthesia (begin from 1 to loss of consciousness) | During anesthesia (up to 6hours) |
| Remimazolam infusion history | The rate of Remimazolam infusion is recorded during anesthesia. | During anesthesia (up to 6hours) |
| Remifentanil infusion history | The target effect-site concentration of remifentanil infusion is recorded during anesthesia. | During anesthesia (up to 6hours) |
| Total amount of remimazolam used (mg/kg/h) | Total amount of remimazolam used (mg/kg/h) during anesthesia. | During anesthesia (up to 6hours) |
| 32530890 | Background | Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877. |
| 31972655 | Background | Schuttler J, Eisenried A, Lerch M, Fechner J, Jeleazcov C, Ihmsen H. Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part I. Pharmacokinetics and Clinical Pharmacodynamics. Anesthesiology. 2020 Apr;132(4):636-651. doi: 10.1097/ALN.0000000000003103. |
| 22190555 | Background | Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20. |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D001941 | Breast Diseases |
| D010279 | Parathyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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