Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05432050

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Remimazolam Anesthesia, General Hypnotics and Sedatives Thyroid Disease Breast Diseases Parathyroid Diseases	Device: Bispectral index and Patient state index monitoring

Study Design

Study Type:

Observational

Anticipated 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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

The percentage of time when bispectral index (BIS) was < 60 [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.)
The percentage of time when patient state index (PSI) was < 50 [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

Heart rate (bpm) [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.
blood pressure (mmHg) [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.
Bispectral index (BIS) during anesthesia [During anesthesia (up to 6hours)]
Bispectral index (BIS) is continuously recorded during anesthesia.
Patient state index (PSI) during anesthesia [During anesthesia (up to 6hours)]
Patient state index (PSI) is continuously recorded during anesthesia.
The percentage of time when bispectral index (BIS) was < 60, and > 40. [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.)
The percentage of time when patient state index (PSI) was < 50, and > 25. [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.)
The last number patient remember that he/she spoke during induction of anesthesia [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)
Remimazolam infusion history [During anesthesia (up to 6hours)]
The rate of Remimazolam infusion is recorded during anesthesia.
Remifentanil infusion history [During anesthesia (up to 6hours)]
The target effect-site concentration of remifentanil infusion is recorded during anesthesia.
Total amount of remimazolam used (mg/kg/h) [During anesthesia (up to 6hours)]
Total amount of remimazolam used (mg/kg/h) during anesthesia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

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