Cholecystitis, Acute, Gallbladder Neoplasms, Acalculous Cholecystitis
Conditions
Brief summary
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
Interventions
DRUGpropofol group
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).
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).
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The principal investigator and the anesthesiologist directly involved in anesthetizing the respective patients should be aware of patient allocation due to the nature of research design and anesthesia maintenance. Two research personnel, who are unaware of the type of test drug (blinding), are not involved in anesthesia but are responsible only for data collection and analysis.
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| frontal spectral power | immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Riker sedation-agitation score | immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU) | 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. |
Countries
South Korea
Outcome results
None listed