Clinical trial NCT05432050: Bispectral Index and Patient State Index During General Anesthesia With Remimazolam
Official title: Bispectral Index and Patient State Index During General Anesthesia With Remimazolam: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Remimazolam
Anesthesia, General
Hypnotics and Sedatives
Thyroid Disease
Breast Diseases
Parathyroid Diseases
Keywords: Patient state index
Bispectral index
Electroencephalography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (ASA class I,II) who need general anesthesia for surger

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.


Eligibility criteria: 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

Primary outcomes:
measure: The percentage of time when bispectral index (BIS) was < 60
timeFrame: During anesthesia (up to 6hours)
measure: The percentage of time when patient state index (PSI) was < 50
timeFrame: During anesthesia (up to 6hours)
Secondary outcomes:
measure: Heart rate (bpm)
timeFrame: During anesthesia (up to 6hours)
measure: blood pressure (mmHg)
timeFrame: During anesthesia (up to 6hours)
measure: Bispectral index (BIS) during anesthesia
timeFrame: During anesthesia (up to 6hours)
measure: Patient state index (PSI) during anesthesia
timeFrame: During anesthesia (up to 6hours)
measure: The percentage of time when bispectral index (BIS) was < 60, and > 40.
timeFrame: During anesthesia (up to 6hours)
measure: The percentage of time when patient state index (PSI) was < 50, and > 25.
timeFrame: During anesthesia (up to 6hours)
measure: The last number patient remember that he/she spoke during induction of anesthesia
timeFrame: During anesthesia (up to 6hours)
measure: Remimazolam infusion history
timeFrame: During anesthesia (up to 6hours)
measure: Remifentanil infusion history
timeFrame: During anesthesia (up to 6hours)
measure: Total amount of remimazolam used (mg/kg/h)
timeFrame: During anesthesia (up to 6hours)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Professor
name: Hee-Soo Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
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.
citation: 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.
citation: 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.