University of Health Sciences Etlik City Hospital
Ankara, Turkey (Türkiye)
NCT Number: NCT06811701
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Observational
Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.
Other names: Scalp nerve block with bupivacaine
Patient in this group will receive IV opioid for pain management before skull pin fixation
Other names: IV fentanyl
"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.
Other names: Lidocaine injection at pin site
Time frame: 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
Time frame: 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.
Diskapi Teaching and Research Hospital
Other
Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies With BIS-DSA (Bıspectral Index-Density Spectral Array) and Hemodynamics
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04050384
Agnosia, Electroencephalography
Columbus, Ohio, United States
View Trial DetailsNCT07719868
Agnosia, Analgesia
View Trial DetailsNCT06694402
Chronic Pain, Chronic Subacromial Impingement Syndrome
Taipei, Taiwan
View Trial DetailsNCT06669585
Cannabis, Chemically-Induced Disorders
Boulder, Colorado, United States
View Trial Details