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Evaluering af respons på smerter fra kraniet pin -fiksering i craniotomies

24. september 2026 opdateret af: Ceyda Ozhan Caparlar, Diskapi Teaching and Research Hospital

Evaluering af respons på smerter fra kraniet pin-fiksering i kraniotomier med BIS-DSA (Bıspectral indeks-densitet spektral array) og hæmodynamik

The goal of this observational study is to investigate the relationship between the response to skull pin fixation pain and the analysis of blood pressure, heart rate, and brain wave activity in adults undergoing brain surgery. The main questions it aims to answer are:

Does the analysis of blood pressure, heart rate, and brain wave activity indicate the patient's response to skull pin fixation pain during brain surgery? How do the methods used to reduce skull pin fixation pain in brain surgeries affect narcotic opioid consumption? The researchers will monitor the patients' response to skull pin fixation pain during surgery through the analysis of brain wave activity.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Adult patients undergoing elective craniotomy under general anesthesia will be evaluated. Methods used to manage pin-related pain will be categorized into three approaches: intravenous opioids, local Methods used to manage pin-related pain will be categorised into three approaches: intravenous opioids, local anaesthetic injection at the pin site, and scalp block. injection at the pin site, and scalp block. The patient's The patient's haemodynamic responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. These records are automatically archived in the BIS-DSA device.Waveform data will be converted into numerical values using a predefined hue-based algorithm.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye)
        • University of Health Sciences Etlik City Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

"This study will include adult patients undergoing elective craniotomy under general anesthesia. Participants will be assigned to different pain management techniques (scalp nerve block, intravenous opioids, or local anesthetic injection) to evaluate their effects on BIS-DSA spectral analysis and hemodynamic responses.

Beskrivelse

Inclusion Criteria:

  • Adult patients aged 18-70 years undergoing elective craniotomy.
  • Patients classified as ASA 1-3 according to the American Society of Anesthesiologists (ASA) classification.
  • Patients scheduled for surgery under general anesthesia.
  • Patients who provide written informed consent to participate in the study.
  • Patients with normal cognitive function (i.e., no diagnosed dementia or severe cognitive impairment).
  • Patients with a preoperative BIS value within the normal range (i.e., no extreme baseline deviations).

Exclusion Criteria:

  • Patients classified as ASA 4 or higher.
  • Patients with neurological disorders (e.g., Parkinson's disease, epilepsy, stroke history).
  • Patients with psychiatric disorders (e.g., severe depression, schizophrenia) that may affect pain perception and response.
  • Patients with known allergies to local anesthetics or opioids.
  • Pregnant or breastfeeding women.
  • Patients with contraindications to anesthesia, including but not limited to:
  • Severe cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction).
  • Severe respiratory disease (e.g., COPD, uncontrolled asthma).
  • Patients with any neurological or pharmacological condition that may interfere with BIS-DSA or EEG measurements.
  • Patients with preoperative chronic opioid use (≥3 months) due to potential tolerance affecting response to intraoperative analgesia.
  • Patients with a history of substance abuse that may alter the BIS response or anesthetic metabolism.
  • Patients with significant hearing or communication impairments, preventing them from understanding or responding to preoperative assessments.
  • Patients with significant scalp pathology (e.g., infections, scars, large vascular malformations) at the BIS electrode placement site, which may interfere with signal acquisition.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group 1: Scalp group

"This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation."
Procedure: Scalp nerve block

Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.

Andre navne:
  • Scalp nerveblok med bupivacaine
Group 2: Opioid Group

"This group consists of patients who receive intravenous opioids for pain management during skull pin fixation."
Medicin: Opioid Anesthetics

Patient in this group will receive IV opioid for pain management before skull pin fixation

Andre navne:
  • IV fentanyl
Group 3: Local Anesthetic Group

"This group consists of patients who receive a local anesthetic injection at the pin site before skull pin fixation."
Procedure: Local Anesthetic Injection

"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.

Andre navne:
  • Lidocaine -injektion på PIN -stedet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in BIS-DSA spectral analysis before and after skull pin fixation
Tidsramme: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.

The primary outcome measure will be the changes in brain wave activity, specifically in the BIS-DSA spectral analysis, before and after skull pin fixation. This will be assessed by comparing the pre- and post-fixation BIS values and spectral features such as alpha dropout, beta arousal, and delta changes
From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
Tidsramme: Baseline to 5 minutes after skull pin fixation.

Hemodynamic response will be evaluated by measuring changes in mean arterial pressure before and after skull pin fixation.
Baseline to 5 minutes after skull pin fixation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Diskapi Teaching and Research Hospital

Efterforskere

  • Ledende efterforsker: Ceyda Ozhan Caparlar, MD, Ankara Etlik City Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. februar 2025

Primær færdiggørelse (Faktiske)

30. oktober 2025

Studieafslutning (Faktiske)

30. januar 2026

Datoer for studieregistrering

Først indsendt

28. januar 2025

Først indsendt, der opfyldte QC-kriterier

5. februar 2025

Først opslået (Faktiske)

6. februar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AESH-BADEK-2024-1016

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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