Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

NCT05432050 | Unknown

• 1 other identifier: H-2204-008-1313
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Patient state index; Bispectral index; Electroencephalography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Heart rate (bpm)

  During anesthesia (up to 6hours)

• blood pressure (mmHg)

  During anesthesia (up to 6hours)

• Bispectral index (BIS) during anesthesia

  During anesthesia (up to 6hours)

• Patient state index (PSI) during anesthesia

  During anesthesia (up to 6hours)

• The percentage of time when bispectral index (BIS) was < 60, and > 40.

  During anesthesia (up to 6hours)

Study Arms (1)

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

Interventions

Bispectral index and Patient state index monitoring DEVICE

The depth of anesthesia will be monitored with both the bispectral index and patient state index at the same time.

Remimazolam anesthesia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients ≥ 19 years need general anesthesia
• American Society of Anesthesiologists (ASA) Classification I, II
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (5)

• 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.

  PMID: 33965206 BACKGROUND

• 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.

  PMID: 32157465 BACKGROUND

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

  PMID: 32530890 BACKGROUND

• 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.

  PMID: 31972655 BACKGROUND

• 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.

  PMID: 22190555 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases; Breast Diseases; Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hee-Soo Kim, MD,PhD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Eun Jang, MD,PhD

CONTACT

082-010-9487-2233; na0ag2@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 27, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)