RecruitingNot ApplicableNCT06922500

Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery

Anesthetic Depth Assessed by Processed EEG (pEEG) - a Comparison of Manual Total Intravenous Anesthesia and Target Controlled Anesthesia in Tumor Resection Via Craniotomy


Sponsor

Region Skane

Enrollment

126 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

An important feature of neurosurgical anesthesia is early postoperative recovery of consciousness with minimal residual sedation. This is a key factor to enable early neurological assessment and early discovery of postoperative complications. The goal of this single centre clinical trial is to compare propofol/remifentanil anesthesia delivered by manual total intravenous anesthesia (mTIVA) or target controlled infusion (TCI) for intracranial tumor resection via craniotomy. Anesthetic depth will be assessed by a simplified processed EEG (pEEG). The main question is time spent within recommended pEEG- levels from anesthesia induction until end of surgery. Secondary questions are: * mean pEEG-level, time from end of surgery to consiousness, * peroperative propofol/remifentanil consumption * postoperative degree of sleepiness * awareness assessment Participants are adults having have planned surgery for open resection of a brain tumor and will receive general anesthesia with propofol and remifentanil randomized to mTIVA or TCI. pEEG vill be blinded. * Participants will be asked to grade postoperative sleepiness using a specific scale * Follow up regarding awareness will be performed.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether processed EEG (brain wave monitoring) technology can accurately measure how deeply anesthetized a patient is during brain tumor removal surgery. Keeping the right level of anesthesia is especially important and complex in brain surgery. **You may be eligible if...** - You are an adult - You are scheduled for elective (planned) brain tumor removal via craniotomy - You have given consent to participate **You may NOT be eligible if...** - You have cognitive difficulties that prevent informed consent - Your surgery is a biopsy only (no resection planned) - The tumor location does not allow placement of the EEG monitoring electrodes on the scalp Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEdepth of anesthesia

Time spent within recommended pEEG-levels


Locations(1)

Anesthesia and Intensive Care, Skane University Hospital

Lund, Sweden

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NCT06922500


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