Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery

NCT06922500 | Recruiting

• 1 other identifier: 2024-01935-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor Adult; Processed EEG; Total Intravenous Anesthesia

Keywords

total intavenous anesthesia, target controlled infusion, processed EEG, open resection of brain tumor,

Outcome Measures

Primary Outcomes (1)

• Amount of time during anestehsia and surgery within recommended levels of processed EEG (pEEG)

  Prior to induction processed EEG (pEEG) will be applied. The pEEG result will not be available to anesthetic personel during surgery. Patients will be anestetised using TIVA or TCI (propofol/remifentanil). Primary endpoint is time within recommended levesl of pEEG.

  During anesthesia

Study Arms (2)

TIVA

ACTIVE COMPARATOR

propofol and remifentanil anesthesia using traditional total intravenous anestesia (mg/kg/min)

Device: depth of anesthesia

TCI

ACTIVE COMPARATOR

Propofol and remifentanil anestesia using target controlled anestesia

Device: depth of anesthesia

Interventions

depth of anesthesia DEVICE

Time spent within recommended pEEG-levels

TCI; TIVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective craniotomy for tumor resection
• Adult patient
• Consent to participation

You may not qualify if:

• Cognitive impact affecting infrmed consent
• brain tumor planned for biopsy without resection Tumor localisation not permitting placement of pEEG electrodes.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Anesthesia and Intensive Care, Skane University Hospital

Lund, 22185, Sweden

RECRUITING

Study Officials

• Malin Rundgren, MD, PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin Rundgren, MD, PhD

CONTACT

+46-46-174242; mailn.rundgren@skane.se

Johan Smålander, CRNA

CONTACT

+46-46-171109; johan.smalander@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: November 21, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

SE (1)