EEG Spectrogram-guided vs. Index-guided Anesthesia for Craniotomy

National Taiwan University

Status: Enrolling

Conditions: Craniotomy

Treatments: Device: Bispectral index; Device: EEG spectrogram

Study type: Interventional

Funder types: Other

Identifiers

NCT06244017

202312067DINA

Details and patient eligibility

About

In this trial, investigators aimed to compared the clinical effects between the electroencephalographic (EEG) spetrogram-guided and processed EEG index-guided multimodal general anesthesia using the combination of propofol, dexmedetomidine, remifentnil and the scalp block in patients undergoing elective craniotomy.

Full description

The multimodal general anesthesia involved the administration of combinations of antinociceptive agents and hypnotics using electroencephalographic (EEG) based monitors to achieve a balanced state of anesthesia. Traditionally, the adjustment of general anesthesia drugs has been done using instruments like the Bispectral Index (BIS), which converts frontal lobe EEG signals into a numerical range of 0-100. This allows anesthesiologists to assess drug dosage and depth of anesthesia. However, numerical conversion may not accurately reflect individual variations and cannot precisely calculate drug concentrations in the case of multiple drug combinations.

For instance, dexmedetomidine (DEX) is currently one of the most commonly used drugs in multimodal generagal anesthesia.Because each anesthetic produces distinct brain states that are readily visible in an EEG density spectral array (DSA) and can be easily interpreted by anesthesiologists, anesthetic titration based on an EEG DSA may provide additional information for anesthetic depth monitoring and may avoid the conventional 'one-index-fits-all' approach, which often ignores the influence of anesthetic drug combination. Theoretically, the anesthetic exposure in cases that involve the coadministration of dexmedetomidine can be more precise through the use of an EEG DSA than the use of BIS value. In accordant to this context, investigators have changed our institutional anesthetic propofol from BIS guidance to the DSA guidance and based on the retrospective analysis, investigators further observed the profound anesthetic-sparing effects and potential postoperative benefits of EEG DSA-guided anesthesia comparing to the BIS-guided anesthesia (doi: 10.4097/kja.23118). Therefore, further prospective randomized controlled is warranted to shape the real clinical benefits of DSA-guided multimodal general anesthesia.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective craniotomy

Exclusion criteria

• revision surgery
• heart failure
• liver cirrhosis > Child B class
• chronic obstructive pulmonary disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

EEG Spectrogram-guided

Experimental group

Description:

The general anesthesia administration is guided by using the EEG spectrogram in this group. Other perioperative care protocols are the same between the two study group.

Treatment:

Device: EEG spectrogram

Bispectral index-guided

Active Comparator group

Description:

The general anesthesia administration is guided by using the processed EEG index, namely the bispectral index (BIS) in this group. Other perioperative care protocols are the same between the two study group.

Treatment:

Device: Bispectral index