Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Diseases; Parathyroid Diseases; Anesthesia, General; Thyroid Disease; Remimazolam; Hypnotics and Sedatives
• Intervention / Treatment: Device: Bispectral index and Patient state index monitoring

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Young-Eun Jang, MD,PhD; Phone Number: 082-010-9487-2233; Email: na0ag2@hotmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
    • Contact: Young-Eun Jang, MD. PhD; Phone Number: 08201094872233; Email: na0ag2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients (ASA class I,II) who need general anesthesia for surger

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remimazolam anesthesia; 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; The depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee-Soo Kim, MD,PhD, Professor

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Bispectral index; Electroencephalography; Patient state index
• Additional Relevant MeSH Terms: Skin Diseases; Endocrine System Diseases; Thyroid Diseases; Breast Diseases; Parathyroid Diseases
• Other Study ID Numbers: H-2204-008-1313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No