Brain Tumor AdultNCT06922487
Assessment of Tiredness During Awake Resection of Intracerebral Tumors
An observational study of Brain Tumor Adult and Awake Surgery, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor Adult, Awake Surgery
- What is being tested?
- Karolinska Sleepiness Scale, KSS
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 11 Nov 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult (>18 years old)
- Elective supra or infratentorial tumor resection via craniotomy
- Surgical need for awake surgery
- Cognitive function allowing informed consent.
Who cannot join
- Tumor resection without awake surgery
- Morbid obesitas
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Intensive and Perioperative Care, Skane University Hospital
Lund, 22185
Malin Rundgren, MD, PhD, +46-46-174242, malin.rundgren@skane.se
Johan Smålander, CRNA
About this study
Official title: Förekomsten av trötthet Vid Neurokirurgisk Vakenkirurgi
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".
Read the detailed description
Background The incidence of primary tumors in the central nervous system in adults in Sweden is approximately 1400 per year. Gliomas constitutes the most common form, approximately 50%. The neurosurgery aims at securing material for pathological-anatomical diagnosis, reduction of symptoms, maximal reduction of tumor mass with minimal functional impact. Occasional patients present with tumors in sensitive areas necessitating operation with the patient awake and co-operable to optimize the resection. The procedure is typically performed as an asleep-awake-asleep procedure. A clinical observation is that the patients tend to become increasingly sleepy/tired during resection. This study aims to quantify this phenomenon.
Methods Ethical review board approval (Dnr 2024-01935-01, Stockholm, Sweden) is present.
The study is a single center kohort study.
Participants will be identified by the neurosurgeon planning tumor resection with intraoperative awake surgery. Inclusion and information are given preoperatively by the neurosurgeon and the anesthetist.
All participants receive propofol/remifentanil based general anesthesia with norepinephrine infusion to support blood-pressure during preparation and craniotomy whereafter the participant is awakened. The resection starts when the participant is coherent and cooperative. Peroperative level of sedation is assessed using Karolinska Sleepiness Scale (KSS) every 15 minutes. KSS is an ordinal nine grade scale assessing sleepiness during the last five minutes from "extremely alert" to "very sleepy, great effort to keep awake, fighting sleep". When the resection is completed the participants receives general anesthesia during wound closure. Postoperative level of sedation is assessed using Karolinska Sleepiness Scale (KSS) during the first two postoperative hours.
Data regarding age, sex, length, weight, comorbidities, tumor location, ASA- classification and preoperative medication will be collected. Peroperative vital parameters and pEEG -results and data from infusion pumps are primarily collected electronically. The manually kept anesthetic notes are copied and stored as back-up. All individual data are de-identified and coded after collection.
Inclusion and exclusion criteria Inclusion Adult (>18 years old) Elective supra or infratentorial tumor resection via craniotomy Surgical need for awake surgery Cognitive function allowing informed consent.
Exclusion Tumor localization not allowing placement of BIS electrodes due to interference with surgery Morbid obesitas
Outcomes Peroperative degree of sleepiness measured with Karolinska Sleepiness Scale (KSS).
Statistical methods and power calculation The study is a descriptive cohort study. A convenience sample of participants fulfilling inclusion criteria during the inclusion time will be used. The primary goal is to include at least 10 participants. As primary KSS variable a deviation of two or more units will be considered a significant change. Time from start of resection until significant change in KSS is the primary endpoint.
- Conditions
- Brain Tumor Adult, Awake Surgery
- Being tested
- Karolinska Sleepiness Scale, KSS
- Keywords
- open resection of intracranial tumor, awake surgery, sleepiness
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karolinska Sleepiness Scale, KSSProcedure or surgery
Assessment of sleepiness during resection using KSS
| Study group | Role | What they receive |
|---|---|---|
| awake surgery | intracranial tumor resection via awake surgery, adult. Receives: Procedure: Karolinska Sleepiness Scale, KSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KSS
Change in KSS during resection
Measured: during surgery and 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start11 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malin Rundgren, MD, PhD, Principal investigator, Anaesthesia and Intensive Care, Skane University hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922487
- Sponsor's protocol ID
- 2024-01935-01 study 4
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will probably be shared after publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Förekomsten av trötthet Vid Neurokirurgisk Vakenkirurgi
- ClinicalTrials.gov ID
- NCT06922487
- Acronym / sponsor ID
- 2024-01935-01 study 4
- Conditions
- Brain Tumor Adult, Awake Surgery
- Keywords
- open resection of intracranial tumor, awake surgery, sleepiness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Detailed description
Background The incidence of primary tumors in the central nervous system in adults in Sweden is approximately 1400 per year. Gliomas constitutes the most common form, approximately 50%. The neurosurgery aims at securing material for pathological-anatomical diagnosis, reduction of symptoms, maximal reduction of tumor mass with minimal functional impact. Occasional patients present with tumors in sensitive areas necessitating operation with the patient awake and co-operable to optimize the resection. The procedure is typically performed as an asleep-awake-asleep procedure. A clinical observation is that the patients tend to become increasingly sleepy/tired during resection. This study aims to quantify this phenomenon.
Methods Ethical review board approval (Dnr 2024-01935-01, Stockholm, Sweden) is present.
The study is a single center kohort study.
Participants will be identified by the neurosurgeon planning tumor resection with intraoperative awake surgery. Inclusion and information are given preoperatively by the neurosurgeon and the anesthetist.
All participants receive propofol/remifentanil based general anesthesia with norepinephrine infusion to support blood-pressure during preparation and craniotomy whereafter the participant is awakened. The resection starts when the participant is coherent and cooperative. Peroperative level of sedation is assessed using Karolinska Sleepiness Scale (KSS) every 15 minutes. KSS is an ordinal nine grade scale assessing sleepiness during the last five minutes from "extremely alert" to "very sleepy, great effort to keep awake, fighting sleep". When the resection is completed the participants receives general anesthesia during wound closure. Postoperative level of sedation is assessed using Karolinska Sleepiness Scale (KSS) during the first two postoperative hours.
Data regarding age, sex, length, weight, comorbidities, tumor location, ASA- classification and preoperative medication will be collected. Peroperative vital parameters and pEEG -results and data from infusion pumps are primarily collected electronically. The manually kept anesthetic notes are copied and stored as back-up. All individual data are de-identified and coded after collection.
Inclusion and exclusion criteria Inclusion Adult (>18 years old) Elective supra or infratentorial tumor resection via craniotomy Surgical need for awake surgery Cognitive function allowing informed consent.
Exclusion Tumor localization not allowing placement of BIS electrodes due to interference with surgery Morbid obesitas
Outcomes Peroperative degree of sleepiness measured with Karolinska Sleepiness Scale (KSS).
Statistical methods and power calculation The study is a descriptive cohort study. A convenience sample of participants fulfilling inclusion criteria during the inclusion time will be used. The primary goal is to include at least 10 participants. As primary KSS variable a deviation of two or more units will be considered a significant change. Time from start of resection until significant change in KSS is the primary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| awake surgery | – | Procedure: Karolinska Sleepiness Scale, KSSintracranial tumor resection via awake surgery, adult. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adult (>18 years old)
- Elective supra or infratentorial tumor resection via craniotomy
- Surgical need for awake surgery
- Cognitive function allowing informed consent.
Key exclusion criteria (2 listed)
- Tumor resection without awake surgery
- Morbid obesitas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Karolinska Sleepiness Scale, KSSAssessment of sleepiness during resection using KSS | Procedure or surgery | awake surgery |
Primary outcome
Change in KSS
Time frame: during surgery and 2 hours postoperatively
Change in KSS during resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided. IPD will probably be shared after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malin Rundgren, MD, PhD principal investigator
Anaesthesia and Intensive Care, Skane University hospital, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor Adult and Awake Surgery, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Smålander, CRNA (+46-47-171109, johan.smalander@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in KSS (time frame: during surgery and 2 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.