Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

Study Overview
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Brief Summary
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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.

Official Title
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Bispectral Index and Patient State Index During General Anesthesia With Remimazolam: a Prospective Observational Study

Conditions
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Remimazolam, Anesthesia, General, Hypnotics and Sedatives, Thyroid Disease, Breast Diseases, Parathyroid Diseases

Intervention / Treatment
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* Device: Bispectral index and Patient state index monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 19 years need general anesthesia American Society of Anesthesiologists (ASA) Classification I, II Written informed consent Exclusion Criteria: American Society of Anesthesiologists (ASA) Classification III, IV, V BMI > 40kg/m^2 Past medical history of anaphylactic reaction to remimazolam, remifentanil, or other benzodiazepines. Administration of anxiolytics, antipsychotics, rifampicin, succinylcholine, neostigmine, flumazenil, and cyclosporin within the past 24 hours Benzodiazepine user (e.g. for seizure control) Transfer to intensive care unit after surgery

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remimazolam anesthesia<br>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. | Device: Bispectral index and Patient state index monitoring<br>* The depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient state index, Bispectral index, Electroencephalography