Actively Recruiting

Age: 18Years +
All Genders
ID06922487

Occurrence of Tiredness During Awake Neurosurgical Tumor Resection

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

10

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults with intracranial tumors who undergo awake brain surgery to remove these tumors while minimizing damage to important brain areas. The study focuses on measuring how tired or sleepy patients become during and shortly after the awake part of the surgery. This is important because understanding the timing and degree of sleepiness can help surgeons plan the procedure better to avoid major disability. Participants receive general anesthesia during preparation and craniotomy, then are awakened to be awake and cooperative during tumor removal. Researchers use the Karolinska Sleepiness Scale (KSS), a nine-point scale to assess sleepiness every 15 minutes during surgery and for two hours after surgery. When the tumor removal is finished, patients are given anesthesia again for wound closure. During the study, data on patient details, tumor characteristics, and anesthesia parameters are collected. Participants will be asked to rate their sleepiness using the KSS during and after surgery. The main measurement is how the KSS score changes over time. The study will include at least 10 participants and aims to describe the pattern of sleepiness during the procedure.

CONDITIONS

Brief Title

Assessment of Tiredness During Awake Resection of Intracerebral Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (over 18 years old)
  • Elective tumor removal via craniotomy in brain areas above or below the tentorium
  • Surgery requires the patient to be awake during part of the operation
  • Able to understand and give informed consent
Not Eligible

You will not qualify if you...

  • Tumor surgery planned without awake procedure
  • Morbid obesity

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and 2 hours postoperatively

Participants undergo awake neurosurgical tumor resection where sleepiness is assessed during surgery. After surgery, participants receive anesthesia during wound closure and have their level of sedation monitored for two hours postoperatively.

1 surgical visit and monitoring during the first 2 hours after surgery

Data Collection

Duration - During surgery and postoperative monitoring

Data including demographics, tumor characteristics, anesthesia details, and sleepiness scores are collected throughout the surgical and immediate postoperative period.

Data collected continuously during surgical and postoperative visits

Trial Site Locations

Total: 1 location

1

Intensive and Perioperative Care, Skane University Hospital

Lund, Sweden, 22185

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Research Team

J

Johan Smålander, CRNA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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