Measuring Tiredness During Awake Brain Tumor Surgery
Förekomsten av trötthet Vid Neurokirurgisk Vakenkirurgi
Region Skane · NCT06922487
This study is testing how tired patients feel during awake brain surgery to help doctors know the best times to remove tumors while the patient is alert.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane (other) |
| Locations | 1 site (Lund) |
| Trial ID | NCT06922487 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the level of tiredness experienced by patients undergoing awake surgery for the resection of intracranial tumors. Using the Karolinska Sleepiness Scale, the study will quantify the degree and speed of sleepiness during the surgical procedure. The goal is to provide surgeons with valuable information on the optimal timing for tumor resection while the patient is awake and cooperative. Participants will be adults scheduled for elective tumor surgery requiring an awake component, and their sleepiness will be evaluated every 15 minutes during the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require elective awake surgery for intracranial tumor resection.
Not a fit: Patients undergoing tumor resection without the need for awake surgery or those with morbid obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes by optimizing the timing of tumor resection during awake surgeries.
How similar studies have performed: While this approach is novel in quantifying tiredness during awake surgery, similar observational studies have shown the importance of patient cooperation in surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years old) * Elective supra or infratentorial tumor resection via craniotomy * Surgical need for awake surgery * Cognitive function allowing informed consent. Exclusion Criteria: * Tumor resection without awake surgery * Morbid obesitas
Where this trial is running
Lund
- Intensive and Perioperative Care, Skane University Hospital — Lund, Sweden (RECRUITING)
Study contacts
- Principal investigator: Malin Rundgren, MD, PhD — Anaesthesia and Intensive Care, Skane University hospital, Lund, Sweden
- Study coordinator: Johan Smålander, CRNA
- Email: johan.smalander@skane.se
- Phone: +46-47-171109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Tumor Adult, Awake Surgery, open resection of intracranial tumor, awake surgery, sleepiness