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EEG Parameters Between Remimazolam- and Propofol-based Anesthesia

NCT ID: NCT06178848

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2023-10-27

Brief Summary

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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

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Conditions

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Cholecystitis, Acute Gallbladder Neoplasms Acalculous Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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).

Group Type EXPERIMENTAL

remimazolam group

Intervention Type 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).

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).

Group Type ACTIVE_COMPARATOR

propofol group

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bon-Nyeo Koo

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Locations

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Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 40279265 (View on PubMed)

Other Identifiers

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4-2022-1405

Identifier Type: -

Identifier Source: org_study_id