Effect of Scalp Block on Bispectral Index Values During Skull Pinning

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.

Study Overview

• Status: Completed
• Conditions: Bispectral Index

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 Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35540
    • Izmir City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective craniotomy for supratentorial mass excision

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients without written approval

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Just before skull pinning
Bispectral index period 2	BIS values between 40-60 show the adequate depth of anesthesia.	1 minute after skull pinning
Bispectral index period 3	BIS values between 40-60 show the adequate depth of anesthesia.	3 minutes after skull pinning
Bispectral index period 4	BIS values between 40-60 show the adequate depth of anesthesia.	5 minutes after skull pinning
Bispectral index period 5	BIS values between 40-60 show the adequate depth of anesthesia.	10 minutes after skull pinning
Bispectral index period 6	BIS values between 40-60 show the adequate depth of anesthesia.	15 minutes after skull pinning

Secondary Outcome Measures

Outcome Measure	Time Frame
systolic blood pressure 1	Just before skull pinning
diastolic blood pressure 1	Just before skull pinning
mean blood pressure 1	Just before skull pinning
Heart rate 1	Just before skull pinning
systolic blood pressure 2	1 minute after skull pinning
diastolic blood pressure 2	1 minute after skull pinning
mean blood pressure 2	1 minute after skull pinning
Heart rate 2	1 minute after skull pinning
systolic blood pressure 3	3 minutes after skull pinning
diastolic blood pressure 3	3 minutes after skull pinning
mean blood pressure 3	3 minutes after skull pinning
heart rate 3	3 minutes after skull pinning
systolic blood pressure 4	5 minutes after skull pinning
diastolic blood pressure 4	5 minutes after skull pinning
mean blood pressure 4	5 minutes after skull pinning
heart rate 4	5 minutes after skull pinning
systolic blood pressure 5	10 minutes after skull pinning
diastolic blood pressure 5	10 minutes after skull pinning
mean blood pressure 5	10 minutes after skull pinning
heart rate 5	10 minutes after skull pinning
systolic blood pressure 6	15 minutes after skull pinning
diastolic blood pressure 6	15 minutes after skull pinning
mean blood pressure 6	15 minutes after skull pinning
heart rate 6	15 minutes after skull pinning

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital
• Investigators: Principal Investigator: Halide Hande ŞAHİNKAYA, MD, Izmir City Hospital; Study Chair: Gözde Gürsoy Çirkinoğlu, MD, Izmir City Hospital; Study Chair: Cafer Ak, MD, Izmir City Hospital; Study Chair: Sermin Altunbaş, MD, Izmir City Hospital; Study Chair: Zeki Tuncel Tekgül, Professor, Izmir City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2025
• Primary Completion (Actual): August 20, 2025
• Study Completion (Actual): August 20, 2025

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 14, 2025
• First Posted (Actual): May 22, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: craniotomy; bispectral index; scalp block; skull pinning
• Other Study ID Numbers: scalp block

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No