Clinical trial NCT06811701: Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies
Official title: Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies With BIS-DSA (Bıspectral Index-Density Spectral Array) and Hemodynamics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Electroencephalography
Craniotomy Surgery
Pain Management
Keywords: depth of anaesthesia
Bispectral index-Density Spectral array
skull clamp pain
noxious
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "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.

Brief summary: 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.

Detailed description: Patients with an ASA (American Society of Anesthesiologists) score of I-II who are undergoing elective craniotomy under general anesthesia with the use of a skull clamp will be included in the study. The methods used to manage patients' pin-related pain will be recorded on the follow-up form: 1-intravenous opioids, 2- local anesthetic (LA) injection at the pin site, and 3- scalp block. The patients' hemodynamic responses and their reactions to painful stimuli, as recorded by the BIS-DSA monitor, will be documented during the placement of the skull clamp. These records are automatically archived in the BIS-DSA device. Waveform analyses from the BIS-DSA will later be converted into numerical values using the "Hue formula."

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18-70 years undergoing elective craniotomy.
* Patients classified as ASA I-II 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 III 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.

Primary outcomes:
measure: Changes in BIS-DSA spectral analysis before and after skull pin fixation
timeFrame: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.
Secondary outcomes:
measure: Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
timeFrame: Baseline to 5 minutes after skull pin fixation.
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Etlik City Hospital
name: Ceyda Ozhan Caparlar, MD
role: PRINCIPAL_INVESTIGATOR
References: