EEG Parameters Between Remimazolam- and Propofol-based Anesthesia

Cholecystitis, Acute Clinical Trial

Official title:

Comparison of Quantitative EEG Parameters During Anesthesia Emergence Between Remimazolam Group and Propofol Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178848
• Other study ID #: 4-2022-1405
• Status: Completed
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: October 27, 2023

Study information

• Verified date: December 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Gallbladder Neoplasms

Intervention

Drug:
• propofol 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).
• remimazolam group
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).

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU)
Secondary	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.	immediately after awakening at the end of the anesthesia, at post-anesthesia care unit (PACU)