Effect of Scalp Block on Bispectral Index Values During Skull Pinning

NCT06984653 | Completed

• 1 other identifier: scalp block
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is there an increase in BIS during skull pin insertion when scalp block is performed?
2. 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.

Conditions

Bispectral Index

Keywords

bispectral index; skull pinning; craniotomy; scalp block

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (24)

• 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

Study Arms (2)

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

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

Patients undergoing elective craniotomy for supratentorial mass excision

You may qualify if:

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

You may not qualify if:

• Patients without written approval

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir City Hospital

Izmir, 35540, Turkey (Türkiye)

Location

Study Officials

• Halide Hande ŞAHİNKAYA, MD

  Izmir City Hospital

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: May 25, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-08

Locations

TU (1)