Actively Recruiting
Anesthetic Depth Assessed by Processed EEG (pEEG) - a Comparison of Manual Total Intravenous Anesthesia and Target Controlled Anesthesia in Tumor Resection Via Craniotomy
Led by Region Skane · Updated on 2025-04-10
126
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating anesthesia methods for adults undergoing planned surgery to remove brain tumors through craniotomy. The study compares two ways of delivering propofol and remifentanil anesthesia: manual total intravenous anesthesia (mTIVA) and target controlled infusion (TCI). The goal is to improve anesthesia monitoring using processed EEG (pEEG) to ensure proper anesthetic depth, which helps enable early neurological assessment and detection of complications after surgery. Participants receive general anesthesia with propofol and remifentanil, randomized to either mTIVA or TCI. The anesthesia depth is monitored with BIS, a processed EEG system, but the monitoring results are concealed from caregivers during surgery. The study measures the time spent within recommended pEEG levels from anesthesia start until surgery ends. Postoperative sedation is assessed using the Karolinska Sleepiness Scale (KSS), and awareness is followed up 1 to 3 days after surgery. Participants are evaluated before surgery and consent to join. Data collected include demographics, tumor details, anesthesia records, and vital signs. Postoperative assessments include sedation levels and awareness checks. The study focuses on how anesthesia methods affect pEEG levels, drug use, time to regain consciousness, and sleepiness after surgery. The total participation involves preoperative assessment, surgery day monitoring, and postoperative follow-up for awareness and sedation.
CONDITIONS
Brief Title
Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective craniotomy for tumor resection
- Adult patient (18 years or older)
- Able to give informed consent
You will not qualify if you...
- Cognitive issues affecting informed consent
- Brain tumor planned for biopsy without resection
- Tumor location preventing placement of pEEG electrodes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks or less
Participants are screened for eligibility to participate in the trial.
1 to 2 visits over a couple of days up to two weeks before surgery (in-person)
Duration - Duration of surgery and anesthesia (hours)
Participants receive general anesthesia using propofol and remifentanil administered by either manual total intravenous anesthesia (mTIVA) or target controlled infusion (TCI) during tumor resection surgery. Anesthetic depth is monitored with concealed processed EEG (pEEG) throughout anesthesia and surgery.
1 day of surgery including anesthesia and monitoring (in-person)
Duration - 3 days
Participants are assessed for postoperative sedation level within the first two hours after surgery and evaluated for awareness during days 1 to 3 after surgery.
Approximately 3 post-operative visits or assessments
Trial Site Locations
Total: 1 location
1
Anesthesia and Intensive Care, Skane University Hospital
Lund, Sweden, 22185
Actively Recruiting
Research Team
M
Malin Rundgren, MD, PhD
J
Johan Smålander, CRNA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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