Anesthesia, General, Breast Diseases, Hypnotics and Sedatives, Parathyroid Diseases, Remimazolam, Thyroid Disease
Conditions
Keywords
Patient state index, Bispectral index, Electroencephalography
Brief summary
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.
Interventions
DEVICEBispectral index and Patient state index monitoring
The depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time.
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time when bispectral index (BIS) was < 60 | During anesthesia (up to 6hours) | 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.) |
| The percentage of time when patient state index (PSI) was < 50 | During anesthesia (up to 6hours) | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure (mmHg) | During anesthesia (up to 6hours) | blood pressure (mmHg) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit. |
| Bispectral index (BIS) during anesthesia | During anesthesia (up to 6hours) | Bispectral index (BIS) is continuously recorded during anesthesia. |
| Patient state index (PSI) during anesthesia | During anesthesia (up to 6hours) | Patient state index (PSI) is continuously recorded during anesthesia. |
| Remifentanil infusion history | During anesthesia (up to 6hours) | The target effect-site concentration of remifentanil infusion is recorded during anesthesia. |
| Remimazolam infusion history | During anesthesia (up to 6hours) | The rate of Remimazolam infusion is recorded during anesthesia. |
| The percentage of time when patient state index (PSI) was < 50, and > 25. | During anesthesia (up to 6hours) | 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.) |
| The last number patient remember that he/she spoke during induction of anesthesia | During anesthesia (up to 6hours) | The last number patient remember that he/she spoke during induction of anesthesia (begin from 1 to loss of consciousness) |
| Total amount of remimazolam used (mg/kg/h) | During anesthesia (up to 6hours) | Total amount of remimazolam used (mg/kg/h) during anesthesia. |
| The percentage of time when bispectral index (BIS) was < 60, and > 40. | During anesthesia (up to 6hours) | 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.) |
| Heart rate (bpm) | During anesthesia (up to 6hours) | Heart rate (bpm) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit. |
Countries
South Korea
Contacts
Primary ContactYoung-Eun Jang, MD,PhD
Outcome results
None listed