EEG Parameters Between Remimazolam- and Propofol-based Anesthesia

Not Applicable

Completed

• Conditions: Acalculous Cholecystitis; Cholecystitis, Acute; Gallbladder Neoplasms
• Interventions: Drug: propofol group; Drug: remimazolam group

• Registration Number: NCT06178848
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-26
• Primary Completion: 2023-10-27
• Study Completion: 2023-10-27
• Status Verified: 2023-12
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

Pregnant women, individuals with arrhythmias, emergency surgeries, obesity (BMI > 30), day-surgery, foreigners, and illiterate individuals.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	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	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of