Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

• Conditions: Hypnotics and Sedatives; Parathyroid Diseases; Remimazolam; Thyroid Disease; Breast Diseases; Anesthesia, General
• Interventions: Device: Bispectral index and Patient state index monitoring

• Registration Number: NCT05432050
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Last Update Submitted: 2022-06-28
• Study Start: 2022-07-01
• Last Update Posted: 2022-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remimazolam anesthesia	Bispectral index and Patient state index monitoring	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of