EEG Parameters Between Remimazolam- and Propofol-based Anesthesia

NCT06178848 | Completed DMC

• 1 other identifier: 4-2022-1405
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Cholecystitis, Acute; Gallbladder Neoplasms; Acalculous Cholecystitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Riker sedation-agitation score

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

Study Arms (2)

propofol group

ACTIVE COMPARATOR

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).

Drug: propofol group

remimazolam group

EXPERIMENTAL

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).

Drug: remimazolam group

Interventions

propofol group DRUG

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).

propofol group

remimazolam group DRUG

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).

remimazolam group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (1)

• Lee Y, Park S, Kim H, Park Y, Lee U, Kwon J, Koo BN, Moon JY. Electroencephalogram Correlates of Delayed Emergence After Remimazolam-Induced Anesthesia Compared to Propofol. Anesth Analg. 2025 Apr 25. doi: 10.1213/ANE.0000000000007516. Online ahead of print.

  PMID: 40279265 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute; Gallbladder Neoplasms; Acalculous Cholecystitis

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Bon-Nyeo Koo

  Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: June 26, 2023
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)