Viewing Study NCT06244017



Ignite Creation Date: 2024-05-06 @ 8:04 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06244017
Status: RECRUITING
Last Update Posted: 2024-02-07
First Post: 2024-01-29

Brief Title: EEG Spectrogram-guided vs Index-guided Anesthesia for Craniotomy
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Comparisons Between Electroencephalographic Spectrogram-guided and Bispectral Index-guided Multimodal General Anesthesia During Craniotomy- a Randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 anesthesiaBecause 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 104097kja23118 Therefore further prospective randomized controlled is warranted to shape the real clinical benefits of DSA-guided multimodal general anesthesia

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None