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).
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.
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;
- Is there an increase in BIS during skull pin insertion when scalp block is performed?
- 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.
- Conditions
- Bispectral Index
- 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 group | Role | What they receive |
|---|---|---|
| Group S | Group of patients who will be performed scalp block | |
| Group LA | Group 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.
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
Bispectral index period 2
BIS values between 40-60 show the adequate depth of anesthesia.
Measured: 1 minute after skull pinning
Bispectral index period 3
BIS values between 40-60 show the adequate depth of anesthesia.
Measured: 3 minutes after skull pinning
Bispectral index period 4
BIS values between 40-60 show the adequate depth of anesthesia.
Measured: 5 minutes after skull pinning
Bispectral index period 5
BIS values between 40-60 show the adequate depth of anesthesia.
Measured: 10 minutes after skull pinning
Bispectral index period 6
BIS values between 40-60 show the adequate depth of anesthesia.
Measured: 15 minutes after skull pinning
Secondary outcomes (24)
systolic blood pressure 1
Measured: Just before skull pinning
diastolic blood pressure 1
Measured: Just before skull pinning
mean blood pressure 1
Measured: Just before skull pinning
Heart rate 1
Measured: Just before skull pinning
systolic blood pressure 2
Measured: 1 minute after skull pinning
diastolic blood pressure 2
Measured: 1 minute after skull pinning
mean blood pressure 2
Measured: 1 minute after skull pinning
Heart rate 2
Measured: 1 minute after skull pinning
systolic blood pressure 3
Measured: 3 minutes after skull pinning
diastolic blood pressure 3
Measured: 3 minutes after skull pinning
mean blood pressure 3
Measured: 3 minutes after skull pinning
heart rate 3
Measured: 3 minutes after skull pinning
systolic blood pressure 4
Measured: 5 minutes after skull pinning
diastolic blood pressure 4
Measured: 5 minutes after skull pinning
mean blood pressure 4
Measured: 5 minutes after skull pinning
heart rate 4
Measured: 5 minutes after skull pinning
systolic blood pressure 5
Measured: 10 minutes after skull pinning
diastolic blood pressure 5
Measured: 10 minutes after skull pinning
mean blood pressure 5
Measured: 10 minutes after skull pinning
heart rate 5
Measured: 10 minutes after skull pinning
systolic blood pressure 6
Measured: 15 minutes after skull pinning
diastolic blood pressure 6
Measured: 15 minutes after skull pinning
mean blood pressure 6
Measured: 15 minutes after skull pinning
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.
- First posted22 May 2025
- Study start25 May 2025
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bispectral IndexStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halide Hande Şahinkaya, Bozyaka Training and Research Hospital
- Investigators
- Halide Hande ŞAHİNKAYA, MD, Principal investigator, Izmir City HospitalGözde Gürsoy Çirkinoğlu, MD, Study chair, Izmir City HospitalCafer Ak, MD, Study chair, Izmir City HospitalSermin Altunbaş, MD, Study chair, Izmir City HospitalZeki Tuncel Tekgül, Professor, Study chair, Izmir City Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Scalp Block on Bispectral Index Values During Skull Pinning; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06984653
- Acronym / sponsor ID
- scalp block
- Conditions
- Bispectral Index
- Keywords
- bispectral index, skull pinning, craniotomy, scalp block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 22 May 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.
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;
- Is there an increase in BIS during skull pin insertion when scalp block is performed?
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | –Group of patients who will be performed scalp block |
| Group LA | – | –Group of patients who will be performed local anesthetic infiltration into pin sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective craniotomy for supratentorial mass excision
Key inclusion criteria (3 listed)
- Patients undergoing elective craniotomy for supratentorial mass excision
- Above 18 years of age
- ASA score I-II-III
Key exclusion criteria (1 listed)
- Patients without written approval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bispectral index period 1
Time frame: Just before skull pinning
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.
Bispectral index period 2
Time frame: 1 minute after skull pinning
BIS values between 40-60 show the adequate depth of anesthesia.
Bispectral index period 3
Time frame: 3 minutes after skull pinning
BIS values between 40-60 show the adequate depth of anesthesia.
Bispectral index period 4
Time frame: 5 minutes after skull pinning
BIS values between 40-60 show the adequate depth of anesthesia.
Bispectral index period 5
Time frame: 10 minutes after skull pinning
BIS values between 40-60 show the adequate depth of anesthesia.
Bispectral index period 6
Time frame: 15 minutes after skull pinning
BIS values between 40-60 show the adequate depth of anesthesia.
24 secondary outcomes
systolic blood pressure 1
Time frame: Just before skull pinning
diastolic blood pressure 1
Time frame: Just before skull pinning
mean blood pressure 1
Time frame: Just before skull pinning
Heart rate 1
Time frame: Just before skull pinning
systolic blood pressure 2
Time frame: 1 minute after skull pinning
diastolic blood pressure 2
Time frame: 1 minute after skull pinning
mean blood pressure 2
Time frame: 1 minute after skull pinning
Heart rate 2
Time frame: 1 minute after skull pinning
systolic blood pressure 3
Time frame: 3 minutes after skull pinning
diastolic blood pressure 3
Time frame: 3 minutes after skull pinning
mean blood pressure 3
Time frame: 3 minutes after skull pinning
heart rate 3
Time frame: 3 minutes after skull pinning
systolic blood pressure 4
Time frame: 5 minutes after skull pinning
diastolic blood pressure 4
Time frame: 5 minutes after skull pinning
mean blood pressure 4
Time frame: 5 minutes after skull pinning
heart rate 4
Time frame: 5 minutes after skull pinning
systolic blood pressure 5
Time frame: 10 minutes after skull pinning
diastolic blood pressure 5
Time frame: 10 minutes after skull pinning
mean blood pressure 5
Time frame: 10 minutes after skull pinning
heart rate 5
Time frame: 10 minutes after skull pinning
systolic blood pressure 6
Time frame: 15 minutes after skull pinning
diastolic blood pressure 6
Time frame: 15 minutes after skull pinning
mean blood pressure 6
Time frame: 15 minutes after skull pinning
heart rate 6
Time frame: 15 minutes after skull pinning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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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. This study is not recruiting at the moment.
Halide Hande ŞAHİNKAYA, MD principal investigator
Izmir City Hospital
Gözde Gürsoy Çirkinoğlu, MD study chair
Izmir City Hospital
Cafer Ak, MD study chair
Izmir City Hospital
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 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.