EEG Parameters Between Remimazolam- and Propofol-based Anesthesia

Yonsei University60 enrolled

Overview

This is an observational study comparing perioperative quantitative EEG parameters between the conventional propofol/remifentanil and remimazolam/remifentanil. We aim to compare and analyze the differences in EEG patterns during the postoperative recovery in a group that underwent remimazolam and remifentanil-based total intravenous anesthesia(TIVA), in comparison to propofol and remifentanil-based TIVA

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Cholecystitis, Acute Gallbladder Neoplasms Acalculous Cholecystitis

Interventions

propofol groupDRUG

During induction, the propofol group initiates with a target-controlled infusion (TCI) of propofol, starting at an effect site concentration of 4.0 ng/ml. After intubation, it is adjusted to maintain an appropriate depth of anesthesia based on the EEG (psi target 40).

remimazolam groupDRUG

The remimazolam group begins with a continuous infusion of remimazolam at 6 mg/kg/hr, which is then adjusted to 1 mg/kg/hr after loss of consciousness to maintain an appropriate depth of anesthesia based on the EEG (psi target 40).

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients aged 19 to 65 years who meet the American Society of Anesthesiologists (ASA) physical status classification 1-3 and undergo laparoscopic cholecystectomy at Severance Hospital. Exclusion Criteria: Pregnant women, individuals with arrhythmias, emergency surgeries, obesity (BMI \> 30), day-surgery, foreigners, and illiterate individuals.

Locations (1)

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

frontal spectral power

Frontal spectral power in EEG (Electroencephalography) refers to the measurement of electrical activity in the frontal lobes of the brain across different frequency bands. Frontal spectral power specifically focuses on the electrical activity in the frontal region of the brain within these frequency bands. Different frequency bands are associated with different states of brain activity. For example, alpha waves are often associated with relaxation or idling of the brain, while beta waves are linked to more active cognitive processing.

Time frame: immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU)

Secondary Outcomes

Riker sedation-agitation score

The Richmond Agitation-Sedation Scale (RASS) is a medical assessment tool used to measure a patient's level of agitation or sedation. The Richmond Agitation-Sedation Scale typically ranges from -5 to +4, with each level representing a specific state of sedation or agitation.

Time frame: immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU)

Data from ClinicalTrials.gov

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