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

Craniotomy Clinical Trial

Official title:

Comparisons Between Electroencephalographic Spectrogram-guided and Bispectral Index-guided Multimodal General Anesthesia During Craniotomy- a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244017
• Other study ID #: 202312067DINA
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: February 2026

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Chun-Yu Wu
• Phone: 886976653376
• Email: b001089018[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing elective craniotomy

Exclusion Criteria:

• revision surgery

• heart failure

• liver cirrhosis > Child B class

• chronic obstructive pulmonary disease

Related Conditions & MeSH terms

• Craniotomy

Intervention

Device:
• EEG spectrogram
In the experimental group, the general anesthesia is guided by using the EEG spectrogram.
• Bispectral index
In the control group, the general anesthesia is guided by using the bispectral index

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative anesthetic dose	We aim to compare the intraoperative propofol consumptions between the two study groups	4-6 hours
Secondary	Postoperative neurological complication incidence	We aim to compare the postoperative neurological complication incidence between the two study groups	During the hospital stays; approximately 7-10 days