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Bispectral IndexNCT06984653

Effect of Scalp Block on Bispectral Index Values During Skull Pinning

An observational study of Bispectral Index, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this prospective observational study is to evaluate the scalp block on bispectral index (BIS) values during skull pinning in patients undergoing craniotomy. The main questions it aims to answer are; 1. Is there an increase in BIS during skull pin insertion when scalp block is performed? 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bispectral Index
How many people
88 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 May 2025to 20 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

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: Patients undergoing elective craniotomy for supratentorial mass excision

Who may be able to join

  • Patients undergoing elective craniotomy for supratentorial mass excision
  • Above 18 years of age
  • ASA score I-II-III

Who cannot join

  • Patients without written approval

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir City Hospital

    Izmir, 35540

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Scalp Block on Bispectral Index Values During Skull Pinning; Prospective Observational Study

The aim of this prospective observational study is to evaluate the scalp block on bispectral index (BIS) values during skull pinning in patients undergoing craniotomy. The main questions it aims to answer are;

  1. Is there an increase in BIS during skull pin insertion when scalp block is performed?
  2. Are there any hemodynamic changes during skull pin insertion when scalp block is performed? Participants will be observed for BIS values and hemodynamic changes during skull pinning.
Read the detailed description

In neurosurgery, maintaining arterial blood pressure within normal limits and keeping the depth of anesthesia under control constitute the basis of anesthesia management in patients undergoing craniotomy. Sudden hemodynamic changes due to inadequate analgesia and depth of anesthesia result in increased intracranial pressure. As a result of increased intracranial pressure, conditions such as hemorrhage and herniation may be encountered in the brain with decreased compliancy due to intracranial space-occupying mass.

Bispectral index (BIS) is a monitoring technique that evaluates the depth of anesthesia and allows optimal anesthetic agent administration. With the help of a sensor placed on the patient's forehead, electroencephalography (EEG) waves are analyzed and converted into numerical data by the processor. The incidence of anesthesia awareness decreases in general anesthesia applications with a BIS value below 60.

Tachycardia and hypertension may develop despite adequate depth of anesthesia with nociculus stimulation at the skin incision during placement of the skull pins. This is especially undesirable in patients with hypertension. Local anesthetic infiltration can be applied to the pin sites or the sensory innervation of the skin can be blocked by scalp block. Previous studies have shown positive effects of local anesthetic infiltration on BIS values during skull pinning.

The primary aim of our study is to evaluate the effect of scalp block on BIS values during skull pin insertion. Secondary aim is to evaluate the hemodynamic changes. The changes will be statistically analyzed between those who will be administered scalp block and those who will not.

The study is planned as a prospective cross-sectional observational study. Patients over 18 years with ASA (American Society of Anesthesiology) score I-II-III who will undergo elective craniotomy for supratentorial mass excision will be included in the study. They will be recorded in two groups as Group S (scalp block) and Group LA (local anesthesia). Scalp block or local anesthetic infiltration will be the choice of the anesthesiologist who is independent of the study and cares for the patient. There will be no intervention in anesthetic applications.

Systolic, diastolic and mean arterial blood pressure, heart rate and bispectral index values before and at 1, 3, 5, 10 and 15 minutes after skull pinnig will be recorded from anesthesia observation form.

Parametric descriptive values will be given as mean and standard deviation, and non-parametric values will be given as n (%) and median and IQR (interquartile range). The conformity of the data to normal distribution will be evaluated by one sample Kolmogorov-Smirnov test. Comparisons of quantitative data conforming to normal distribution will be made with Student T test and comparisons of data not conforming to normal distribution will be made with Mann Whitney U test. Chi-Square test will be used to compare qualitative data. For the analyses, the significance level will be accepted as p<0.05 at 95% confidence interval.

Keywords
bispectral index, skull pinning, craniotomy, scalp block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06984653
Study groupRoleWhat they receive
Group SGroup of patients who will be performed scalp block
Group LAGroup of patients who will be performed local anesthetic infiltration into pin sites

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bispectral index period 1

    Bispectral index value will be noted through BIS monitoring via the BIS sensor attached to the frontal area. BIS index is a numerical scale between 0 and 100, where 100 is completely awake and 0 is isoelectric status. BIS value between 40-60 shows the adequate depth of anesthesia.

    Measured: Just before skull pinning

  2. Bispectral index period 2

    BIS values between 40-60 show the adequate depth of anesthesia.

    Measured: 1 minute after skull pinning

  3. Bispectral index period 3

    BIS values between 40-60 show the adequate depth of anesthesia.

    Measured: 3 minutes after skull pinning

  4. Bispectral index period 4

    BIS values between 40-60 show the adequate depth of anesthesia.

    Measured: 5 minutes after skull pinning

  5. Bispectral index period 5

    BIS values between 40-60 show the adequate depth of anesthesia.

    Measured: 10 minutes after skull pinning

  6. Bispectral index period 6

    BIS values between 40-60 show the adequate depth of anesthesia.

    Measured: 15 minutes after skull pinning

Secondary outcomes (24)
  1. systolic blood pressure 1

    Measured: Just before skull pinning

  2. diastolic blood pressure 1

    Measured: Just before skull pinning

  3. mean blood pressure 1

    Measured: Just before skull pinning

  4. Heart rate 1

    Measured: Just before skull pinning

  5. systolic blood pressure 2

    Measured: 1 minute after skull pinning

  6. diastolic blood pressure 2

    Measured: 1 minute after skull pinning

  7. mean blood pressure 2

    Measured: 1 minute after skull pinning

  8. Heart rate 2

    Measured: 1 minute after skull pinning

  9. systolic blood pressure 3

    Measured: 3 minutes after skull pinning

  10. diastolic blood pressure 3

    Measured: 3 minutes after skull pinning

  11. mean blood pressure 3

    Measured: 3 minutes after skull pinning

  12. heart rate 3

    Measured: 3 minutes after skull pinning

  13. systolic blood pressure 4

    Measured: 5 minutes after skull pinning

  14. diastolic blood pressure 4

    Measured: 5 minutes after skull pinning

  15. mean blood pressure 4

    Measured: 5 minutes after skull pinning

  16. heart rate 4

    Measured: 5 minutes after skull pinning

  17. systolic blood pressure 5

    Measured: 10 minutes after skull pinning

  18. diastolic blood pressure 5

    Measured: 10 minutes after skull pinning

  19. mean blood pressure 5

    Measured: 10 minutes after skull pinning

  20. heart rate 5

    Measured: 10 minutes after skull pinning

  21. systolic blood pressure 6

    Measured: 15 minutes after skull pinning

  22. diastolic blood pressure 6

    Measured: 15 minutes after skull pinning

  23. mean blood pressure 6

    Measured: 15 minutes after skull pinning

  24. heart rate 6

    Measured: 15 minutes after skull pinning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start25 May 2025
  3. Primary completion20 Aug 2025
  4. Study completion20 Aug 2025

Resources

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
Other
Time perspective
Prospective
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06984653
Sponsor's protocol ID
scalp block
Status last verified
Aug 2025
First submitted
14 May 2025
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bispectral Index, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 28 Nov 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bispectral index period 1 (time frame: Just before skull pinning). The study lists 6 primary outcomes in all. 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 28 Nov 2025.

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