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Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery

NCT06922500 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-04-10

No results posted yet for this study

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.

Conditions

  • Brain Tumor Adult
  • Processed EEG
  • Total Intravenous Anesthesia

Interventions

DEVICE

depth of anesthesia

Time spent within recommended pEEG-levels

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Malin Rundgren, MD, PhD · Region Skane

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922500 on ClinicalTrials.gov