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RemimazolamNCT05432050

Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

An observational study of Remimazolam and Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Bispectral index and Patient state index monitoring
Type of treatment
Medical device
How many people
40 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2022to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Young-Eun Jang, MD,PhD contact

082-010-9487-2233

na0ag2@hotmail.com

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

    Hee-Soo Kim, MD.PhD, 08201052878006, dami0605@snu.ac.kr

    Young-Eun Jang, MD. PhD, 08201094872233, na0ag2@hotmail.com

Other trials in South Korea

About this study

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.

Being tested
Bispectral index and Patient state index monitoring
Keywords
Patient state index, Bispectral index, Electroencephalography
Medical subject headings
Thyroid Diseases, Breast Diseases, Parathyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bispectral index and Patient state index monitoringDevice

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

Study groups in NCT05432050
Study groupRoleWhat they receive
Remimazolam anesthesiaGeneral 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.
Receives: Device: Bispectral index and Patient state index monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: During anesthesia (up to 6hours)

  2. 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.)

    Measured: During anesthesia (up to 6hours)

Secondary outcomes (10)

  1. Heart rate (bpm)

    Heart rate (bpm) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit.

    Measured: During anesthesia (up to 6hours)

  2. blood pressure (mmHg)

    blood pressure (mmHg) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit.

    Measured: During anesthesia (up to 6hours)

  3. Bispectral index (BIS) during anesthesia

    Bispectral index (BIS) is continuously recorded during anesthesia.

    Measured: During anesthesia (up to 6hours)

  4. Patient state index (PSI) during anesthesia

    Patient state index (PSI) is continuously recorded during anesthesia.

    Measured: During anesthesia (up to 6hours)

  5. 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.)

    Measured: During anesthesia (up to 6hours)

  6. 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.)

    Measured: During anesthesia (up to 6hours)

  7. 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)

    Measured: During anesthesia (up to 6hours)

  8. Remimazolam infusion history

    The rate of Remimazolam infusion is recorded during anesthesia.

    Measured: During anesthesia (up to 6hours)

  9. Remifentanil infusion history

    The target effect-site concentration of remifentanil infusion is recorded during anesthesia.

    Measured: During anesthesia (up to 6hours)

  10. Total amount of remimazolam used (mg/kg/h)

    Total amount of remimazolam used (mg/kg/h) during anesthesia.

    Measured: During anesthesia (up to 6hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05432050
Sponsor's protocol ID
H-2204-008-1313
Status last verified
Jun 2022
First submitted
20 Jun 2022
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33965206

  • 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.

    PubMed 32157465

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

    PubMed 32530890

  • 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.

    PubMed 31972655

  • 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.

    PubMed 22190555

Questions about this trial

What is this clinical trial studying?

An observational study of Remimazolam and Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Young-Eun Jang, MD,PhD (082-010-9487-2233, na0ag2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of time when bispectral index (BIS) was < 60 (time frame: During anesthesia (up to 6hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432050, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

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