EEG DSA-guided Intravenous Anesthesia Using Dexmedetomidine and Propofol

Brain Surgery Clinical Trial

Official title:

Anesthetic Sparing Effects of Dexmedetomidine During Craniotomy: a Retrospective Propensity Score Matching Comparison Between Encephalographic Spectrogram-guided and Processes Encephalographic Index-guided Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656547
• Other study ID #: 202211078RINC
• Status: Recruiting
• Start date: December 12, 2022
• Est. completion date: February 25, 2023

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital
• Contact: Chun-Yu Wu
• Phone: 886-2-23562158
• Email: b001089018[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators conduct this retrospective analysis to test this hypothesis that the EEG spectrogram guided general anesthesia with dexmedetomidine co-administration with propofol may significantly reduce the propofol consumption during craniotomy and to investigate potential benefits on postoperative outcomes.

Description:

The bispectral index (BIS), is widely applied to maintain anesthetic depth. However, this processed EEG index may be ambiguous when dexmedetomidine is administrated. Because each anesthetic produces distinct brain states that are readily visible in the EEG spectrogram which can be easily interpreted by anesthesiologists, the EEG spectrogram-guided anesthesia is theoretically beneficial to avoid unnecessary anesthetic exposure when dexmedetomidine is co-administrated but this remains not yet clarified. Recently, the investigators reported a randomized controlled trial which revealed that co-administration of dexmedetomidine with propofol by using the BIS score guidance, is associated with profound propofol sparing effects and more favorable postoperative neurological outcomes (Eur J Anaesthesiol . 2021 Dec 1;38(12):1262-1271.). Based on the advance of knowledge of EEG spectrogram, the investigators have transited our practice based on the EEG spectrogram guidance. In this study, the investigators analyze the influence of EEG spectrogram guidance on the propofol sparing effect and the postoperative profile in comparison to patients of our previous BIS-guided protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression

• age between 20 to 80 yr

Exclusion Criteria:

• Fever, elevated white blood cell or C-reactive protein

• Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class

• Impaired renal function, cGFR< 60 ml/min/1.73 m2

• Cardiac dysfunction, such as heart failure > NYHA class II

Related Conditions & MeSH terms

• Brain Surgery

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	Propofol dose requirement	Intraoperative propofol consumption	4-6 hours
Secondary	Postoperative delirium	Postoperative delirium diagnosed using the Intensive Care Delirium Screening Checklist (ICDSC) criteria	During hospital stay, estimated 7-10 days
Secondary	Postoperative Barthel index change	Barthel index changes between the states of admission and discharge	During hospital stay, estimated 7-10 days