Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432050
• Other study ID #: H-2204-008-1313
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Seoul National University Hospital
• Contact: Young-Eun Jang, MD,PhD
• Phone: 082-010-9487-2233
• Email: na0ag2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• Bispectral 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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

Outcome

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)