NCT06922500 Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery
| NCT ID | NCT06922500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Brain Tumor Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2024-11-21 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Elective craniotomy for tumor resection * Adult patient * Consent to participation Exclusion Criteria: * Cognitive impact affecting infrmed consent * brain tumor planned for biopsy without resection Tumor localisation not permitting placement of pEEG electrodes.
Contact & Investigator
Malin Rundgren, MD, PhD
PRINCIPAL INVESTIGATOR
Region Skane
Frequently Asked Questions
Who can join the NCT06922500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumor Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06922500 currently recruiting?
Yes, NCT06922500 is actively recruiting participants. Contact the research team at mailn.rundgren@skane.se for enrollment information.
Where is the NCT06922500 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT06922500 clinical trial?
NCT06922500 is sponsored by Region Skane. The principal investigator is Malin Rundgren, MD, PhD at Region Skane. The trial plans to enroll 126 participants.