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Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

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ClinicalTrials.gov Identifier: NCT05432050
Recruitment Status : Not yet recruiting
First Posted : June 27, 2022
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment
Remimazolam Anesthesia, General Hypnotics and Sedatives Thyroid Disease Breast Diseases Parathyroid Diseases Device: Bispectral index and Patient state index monitoring

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bispectral Index and Patient State Index During General Anesthesia With Remimazolam: a Prospective Observational Study
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

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.




Primary Outcome Measures :
  1. The percentage of time when bispectral index (BIS) was < 60 [ Time Frame: During anesthesia (up to 6hours) ]
    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.)

  2. The percentage of time when patient state index (PSI) was < 50 [ Time Frame: During anesthesia (up to 6hours) ]
    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.)


Secondary Outcome Measures :
  1. Heart rate (bpm) [ Time Frame: During anesthesia (up to 6hours) ]
    Heart rate (bpm) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit.

  2. blood pressure (mmHg) [ Time Frame: During anesthesia (up to 6hours) ]
    blood pressure (mmHg) measured before induction of anesthesia, at loss of consciousness, and before transfer to post-anesthesia care unit.

  3. Bispectral index (BIS) during anesthesia [ Time Frame: During anesthesia (up to 6hours) ]
    Bispectral index (BIS) is continuously recorded during anesthesia.

  4. Patient state index (PSI) during anesthesia [ Time Frame: During anesthesia (up to 6hours) ]
    Patient state index (PSI) is continuously recorded during anesthesia.

  5. The percentage of time when bispectral index (BIS) was < 60, and > 40. [ Time Frame: During anesthesia (up to 6hours) ]
    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.)

  6. The percentage of time when patient state index (PSI) was < 50, and > 25. [ Time Frame: During anesthesia (up to 6hours) ]
    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.)

  7. The last number patient remember that he/she spoke during induction of anesthesia [ Time Frame: During anesthesia (up to 6hours) ]
    The last number patient remember that he/she spoke during induction of anesthesia (begin from 1 to loss of consciousness)

  8. Remimazolam infusion history [ Time Frame: During anesthesia (up to 6hours) ]
    The rate of Remimazolam infusion is recorded during anesthesia.

  9. Remifentanil infusion history [ Time Frame: During anesthesia (up to 6hours) ]
    The target effect-site concentration of remifentanil infusion is recorded during anesthesia.

  10. Total amount of remimazolam used (mg/kg/h) [ Time Frame: During anesthesia (up to 6hours) ]
    Total amount of remimazolam used (mg/kg/h) during anesthesia.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients (ASA class I,II) who need general anesthesia for surger
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05432050


Contacts
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Contact: Young-Eun Jang, MD,PhD 082-010-9487-2233 na0ag2@hotmail.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Contact: Hee-Soo Kim, MD.PhD    08201052878006    dami0605@snu.ac.kr   
Contact: Young-Eun Jang, MD. PhD    08201094872233    na0ag2@hotmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Soo Kim, MD,PhD Professor
Publications:
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Responsible Party: Hee-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05432050    
Other Study ID Numbers: H-2204-008-1313
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hee-Soo Kim, Seoul National University Hospital:
Patient state index
Bispectral index
Electroencephalography
Additional relevant MeSH terms:
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Breast Diseases
Thyroid Diseases
Parathyroid Diseases
Endocrine System Diseases
Skin Diseases