EVALUATION OF POSTOPERATIVE NEUROCOGNITIVE IMPAIRMENT

NCT06685770 | Active Not Recruiting

• 1 other identifier: HEA-AAR-EK-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurocognitive Disorder; General Anesthesia; Total Intravenous Anesthesia; Sevoflurane Anaesthesia; Breast Surgery

Keywords

neurocognitive disorder; general anesthesia; mini mental state assessment; mini-cog test

Outcome Measures

Primary Outcomes (1)

• Decrease in Mini Mental State Assessment test

  Female patients who will undergo breast cancer surgery will be given a mini mental state assessment test at the preoperative 24th hour, before and after surgery, and on the 1st, 3rd, and 5th postoperative days. In this test, the patient's neurocognitive status will be evaluated by asking simple questions that investigate their mental characteristics. Each question has a score and the total score indicates the patient's condition. In these patients, this test will be repeated at regular intervals after surgery and postoperatively and the results will be recorded.High scores on this test indicate good neurological stability, whereas falling is associated with poor neurological status. Changed in the value as a result of this test will be investigated.

  Preoperative 24 hours before, in the preoperative operating room, at the 1st postoperative hour, on the 1st, 3rd, 5th postoperative days.

Secondary Outcomes (1)

• Mini-cog test

  Preoperative 24 hours before, in the preoperative operating room, at the 1st postoperative hour, on the 1st, 3rd, 5th postoperative days.

Study Arms (2)

total intravenous anesthesia groups

In this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo surgery for breast cancer. All patients will be followed during the perioperative period according to the standards specified in the American Society of Anesthesia guideline. Neurological evaluations will be performed at the 24th hour before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who underwent total intravenous anesthesia after peroperative anesthesia management will constitute this group. The total amounts of propofol and remifentanil consumed in this group will be recorded.

Other: Mini mental state assessment test; Other: Mini-cog test

inhaled anesthesia groups

In this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo surgery for breast cancer. All patients will be followed during the perioperative period according to the standards specified in the American Society of Anesthesia guideline. Neurological evaluations will be performed at the 24th hour before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who received inhaler anesthesia after peroperative anesthesia management will constitute this group. In this group, Minimal alveolar concentration levels of sevoflurane and total amounts of remifentanil will be recorded.

Other: Mini mental state assessment test; Other: Mini-cog test

Interventions

Mini mental state assessment test OTHER

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.

Also known as: neurocognitive assessment test

inhaled anesthesia groups; total intravenous anesthesia groups

Mini-cog test OTHER

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.

Also known as: neurocognitive assessment test

inhaled anesthesia groups; total intravenous anesthesia groups

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients who applied to the general surgery clinic of Haseki Training and Research Hospital due to the diagnosis of early stage breast cancer (stage 1-2) and planned breast-conserving surgery (mass removal only) will be included in this study. Since the neurocognitive status assessment will be made precisely in these patients, diseases and factors affecting the neurological status will be recorded as non-study factors and these patients will be excluded from the study. Preoperative anxiety scores, comorbidities and regular medications of the patients included in the study will also be recorded.

You may qualify if:

• Female patients with early stage breast cancer who will undergo breast-conserving surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34265, Turkey (Türkiye)

Location

Related Publications (2)

• Jo YY, Kim JY, Lee JY, Choi CH, Chang YJ, Kwak HJ. The effect of intraoperative dexmedetomidine on acute kidney injury after pediatric congenital heart surgery: A prospective randomized trial. Medicine (Baltimore). 2017 Jul;96(28):e7480. doi: 10.1097/MD.0000000000007480.

  PMID: 28700489 BACKGROUND

• Bocskai T, Kovacs M, Szakacs Z, Gede N, Hegyi P, Varga G, Pap I, Toth I, Revesz P, Szanyi I, Nemeth A, Gerlinger I, Karadi K, Lujber L. Is the bispectral index monitoring protective against postoperative cognitive decline? A systematic review with meta-analysis. PLoS One. 2020 Feb 13;15(2):e0229018. doi: 10.1371/journal.pone.0229018. eCollection 2020.

  PMID: 32053678 BACKGROUND

MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Oznur Sen, Associate Professor

  Haseki Training and Research Hospital

  STUDY DIRECTOR

• Munevver Kayhan, Medical Doctor

  Haseki Training and Research Hospital

  STUDY CHAIR

• Esra Kahya Tepe, Medical Resident Doctor

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: November 12, 2024
• Primary Completion: February 15, 2025
• Study Completion: May 15, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)