EEG DSA-guided Intravenous Anesthesia Using Dexmedetomidine and Propofol

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Chun-Yu Wu; Phone Number: 886-2-23562158; Email: b001089018@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chun-Yu Wu; Phone Number: 886-2-23562158; Email: b001089018@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Encephalographic spectrogram group; The dexmedetomidine and propofol infusions were titrated to maintain robust alpha power in the encephalographic spectrogram
Encephalographic index group; The dexmedetomidine and propofol infusions were titrated to maintain the bispectral index score between 40 and 60.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol dose requirement	Intraoperative propofol consumption	4-6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	Postoperative delirium diagnosed using the Intensive Care Delirium Screening Checklist (ICDSC) criteria	During hospital stay, estimated 7-10 days
Postoperative Barthel index change	Barthel index changes between the states of admission and discharge	During hospital stay, estimated 7-10 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Anticipated): January 25, 2023
• Study Completion (Anticipated): February 25, 2023

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: dexmedetomidine; craniotomy; electroencephalogram; total intravenous anesthesia
• Other Study ID Numbers: 202211078RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No