Assessment of Tiredness During Awake Resection of Intracerebral Tumors

NCT06922487 | Recruiting

• 1 other identifier: 2024-01935-01 study 4
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Occasional patients with intracranial tumors need to have a planned awakening during surgery to avoid major disability from the tumor resection. During the awake part of the surgery an increasing degree of tiredness is observed. For the surgeon to plan the resection knowledge of the degree and speed of tiredness/sleepiness evolution is important. The goal of this single center study is to use the "Karolinska Sleepiness Scale" during and after awake surgery for neurosurgical tumor resection to quantify the time available for surgical intervention. Participants are adults having planned surgery for open resection of intracranial tumor with a planned awakening for assessment during surgery. Participants will be asked to grade postoperative sleepiness using the "Karolinska Sleepiness Scale".

Conditions

Brain Tumor Adult; Awake Surgery

Keywords

open resection of intracranial tumor; awake surgery; sleepiness

Outcome Measures

Primary Outcomes (1)

• Change in KSS

  Change in KSS during resection

  during surgery and 2 hours postoperatively

Study Arms (1)

awake surgery

intracranial tumor resection via awake surgery, adult.

Procedure: Karolinska Sleepiness Scale, KSS

Interventions

Karolinska Sleepiness Scale, KSS PROCEDURE

Assessment of sleepiness during resection using KSS

awake surgery

Eligibility Criteria

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

Study Population

Participants presenting to the neurosurgical unit, Skane University hospital, Lund, Sweden for resection of intracranial tumor via craniotomy assessed to benefit from awake surgery.

You may qualify if:

• Adult (\>18 years old)
• Elective supra or infratentorial tumor resection via craniotomy
• Surgical need for awake surgery
• Cognitive function allowing informed consent.

You may not qualify if:

• Tumor resection without awake surgery
• Morbid obesitas

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Intensive and Perioperative Care, Skane University Hospital

Lund, 22185, Sweden

RECRUITING

MeSH Terms

Conditions

Sleepiness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Malin Rundgren, MD, PhD

  Anaesthesia and Intensive Care, Skane University hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Smålander, CRNA

CONTACT

+46-47-171109; johan.smalander@skane.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

SE (1)