Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06922500

Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery

Led by Region Skane · Updated on 2025-04-10

126

Participants Needed

1

Research Sites

136 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Elective craniotomy for tumor resection
  • Adult patient (18 years or older)
  • Ability and willingness to give informed consent
Not Eligible

You will not qualify if you...

  • Cognitive impairment affecting ability to give informed consent
  • Brain tumor planned for biopsy only, without tumor removal
  • Tumor location that does not allow placement of processed EEG electrodes

AI-Screening

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Trial Site Locations

Total: 1 location

1

Anesthesia and Intensive Care, Skane University Hospital

Lund, Sweden, 22185

Actively Recruiting

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Research Team

M

Malin Rundgren, MD, PhD

CONTACT

J

Johan Smålander, CRNA

CONTACT

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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