Anesthesia, General Clinical Trial
Official title:
Bispectral Index and Patient State Index During General Anesthesia With Remimazolam: a Prospective Observational Study
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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. — View Citation
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. — View Citation
Schüttler 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. — View Citation
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. Review. — View Citation
Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | Bispectral index (BIS) during anesthesia | Bispectral index (BIS) is continuously recorded during anesthesia. | During anesthesia (up to 6hours) | |
Secondary | Patient state index (PSI) during anesthesia | Patient state index (PSI) is continuously recorded during anesthesia. | During anesthesia (up to 6hours) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Remimazolam infusion history | The rate of Remimazolam infusion is recorded during anesthesia. | During anesthesia (up to 6hours) | |
Secondary | Remifentanil infusion history | The target effect-site concentration of remifentanil infusion is recorded during anesthesia. | During anesthesia (up to 6hours) | |
Secondary | Total amount of remimazolam used (mg/kg/h) | Total amount of remimazolam used (mg/kg/h) during anesthesia. | During anesthesia (up to 6hours) |
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