Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

NCT05423080

Adult Anesthesia, General

COMPLETED PHASE4

Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol

NCT05435911

Recovery

COMPLETED NA

Binaural Sound for Remimazolam Induction

NCT06099977

General Anesthesia Prostate Cancer Uterine Myoma

RECRUITING NA

Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery

NCT05412914

Surgical Procedure, Unspecified

UNKNOWN PHASE4

Binaural Sound for Remimazolam Maintenance

NCT06497283

General Anesthesia Prostate Cancer Stage Uterine Myoma

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Bispectral index and Patient state index monitoring

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No