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Processed EEG for Monitoring of Anesthetic Depth in Intracranial Tumor Surgery
Study Purpose
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 will be asked to grade postoperative sleepiness using a specific scale.
- - Follow up regarding awareness will be performed.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06922500 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Region Skane |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Malin Rundgren, MD, PhD |
Principal Investigator Affiliation | Region Skane |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Sweden |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain Tumor Adult, Processed EEG, Total Intravenous Anesthesia |
Contact a Trial Team
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