Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

Seoul National University

Status: Not yet enrolling

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

Treatments: Device: Bispectral index and Patient state index monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT05432050

H-2204-008-1313

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Remimazolam anesthesia

Description:

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.

Treatment:

Device: Bispectral index and Patient state index monitoring