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Clinical Trials in Turkey / NCT06685770
Active, not recruiting Observational

EVALUATION OF POSTOPERATIVE NEUROCOGNITIVE IMPAIRMENT

NCT06685770 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2024-11-12
Last updated
2024-11-14

Condition(s) studied

Neurocognitive DisorderGeneral AnesthesiaTotal Intravenous AnesthesiaSevoflurane AnaesthesiaBreast Surgery

Investigational drug(s) / intervention(s)

Mini mental state assessment testMini-cog test

Mini mental state assessment test: Breast cancer is a very common and important disease in the female population around the world. Anesthesia management during surgery for this disease in the postoperative period should be carefully planned. It will be important to examine the neurocognitive effects of anesthesia management in the postoperative period in this patient group. Today, inhaler and total intravenous anesthesia have advantages as well as disadvantages. It would be valuable to examine its neurocognitive effects in this patient group. In this study, the frequently used Mini mental state assessment test and Mini-cog test will be used.With mini mental state assessment, the patient is asked a number of simple questions to evaluate cognitive functions and each question has certain points. Changes in these score levels preoperatively and postoperatively will be compared within each patient. At the end of the study, preoperative and postoperative changes will be compared statistically between the groups.

Mini-cog test: Breast cancer is a very common and important disease in the female population around the world. Anesthesia management during surgery for this disease in the postoperative period should be carefully planned. It will be important to examine the neurocognitive effects of anesthesia management in the postoperative period in this patient group. Today, inhaler and total intravenous anesthesia have advantages as well as disadvantages. It would be valuable to examine its neurocognitive effects in this patient group. In this study, the frequently used Mini-cog test will be used.With Mini-cog test, the patient is asked a number of simple questions to evaluate cognitive functions and each question has certain points. Changes in these score levels preoperatively and postoperatively will be compared within each patient. At the end of the study, preoperative and postoperative changes will be compared statistically between the groups.

Study summary

In this prospective study, the effects of different anesthesia methods (total intravenous anesthesia and inhaled anesthesia) on neurocognitive function will be examined in patients undergoing breast-conserving surgery without axillary lymph node dissection. Mini-Mental State Examination and Mini-Cog tests will be administered at specific intervals pre and postoperatively. Anesthesia management will follow standard protocols, and the researcher will not intervent in these processes. The relationship between the type of anesthesia and neurocognitive outcomes will be evaluated based on the collected data.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Female patients with early stage breast cancer who will undergo breast-conserving surgery Exclusion Criteria: * Patients receiving neoadjuvant radiotherapy and chemotherapy * Patients who will undergo axillary lymph dissection and total mastectomy * Asa 4-5 patients * Patients without voluntary consent * Patients with previous surgery or vertebrobasilar insufficiency * Patients with Carotis stenosis * Patients with a visual analog scale above 4 in the postoperative recovery unit * Patients in whom cerebral oxygenation decreased by 15% from the beginning in cerebral oximetry monitoring during the perioperative period * Patients with bleeding that disrupts hemodynamics during follow-up and bleeding greater than 20% of body volume * Patients with postoperative intensive care unit follow-up * Patients with a decrease of more than 20% from the baseline systolic value (based on ward monitoring) during follow-up * Patients with intraoperative ventilation failure, patients with hypercarbia, hypocarbia * Patients whose Patient State Index value falls below 25, which is sufficient for the depth of anesthesia, during anesthesia induction or maintenance. * Patients with known neurological, psychiatric, unstable cardiovascular, renal or hepatic system disease * Patients with Uncontrolled Hypertension * Patients with greater than 1st degree heart block * Patients allergic to α2 adrenergic receptor agonist * Patients who cannot speak and do not know Turkish * Alcohol and substance addicted patients * Patients who have used opioids in the last 24 hours * Patients who developed sepsis during postoperative follow-up * Patients with a history of recurrent surgery

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Haseki Training and Research Hospital Istanbul Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06685770 on ClinicalTrials.gov ↗ ← All trials in Turkey