NCT06685770

EVALUATION OF POSTOPERATIVE NEUROCOGNITIVE IMPAIRMENT

THE EFFECT OF PEROPERATIVE TOTAL INTRAVENOUS ANESTHESIA AND INHALER ANESTHESIA ON POSTOPERATIVE NEUROCGNITIVE DISORDER IN BREAST CANCER SURGERY

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Haseki Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

During the preoperative evaluation process, after identifying patients with breast cancer who will undergo breast-conserving surgery and who will not undergo axillary lymph dissection, who meet the inclusion criteria in the study, neurocognitive evaluations of these patients will be performed by the anesthesiologist with the mini-mental state assessment (MMDD) test and Mini-cog test 24 hours before the preoperative period. These two tests will be repeated by the same doctor in the preoperative waiting room on the day of the operation. From the preoperative waiting room, patients will be taken to the operation room after premedication with 2mg intravenous midazolam. After all patients are monitored with standard American Society of Anesthesia monitoring (heart rate, peripheral saturation, noninvasive artery monitoring) and electro encephalography monitoring (patient state index (PSI)), the initial values will be recorded before surgery. During induction, 1-2mg/kg propofol, 2mcg/kg Fentanyl and 0.8mg/kg rocuronium will be administered and then the patient will be intubated. Patients will be monitored to be normothermic by body temperature monitoring. If peroperative heart rate and noninvasive arterial pressure values increase by more than 20% of the presurgical basal value, remifentanil will be administered as an intravenous infusion between 0.05-2mcg/kg/min to all patients. During the peroperative period, noninvasive arterial pressure values, saturation values, heart rate, Patient state index values, Suppression rates and times, body temperature values will be recorded on the follow up form as values before the operation, at the beginning of the operation, at 30minute intervals from the beginning of the operation, and before and after extubation at the end of the operation. During surgery, peroperative anesthesia management will be determined as the ideal anesthesia method for the patient, as deemed appropriate by the relevant anesthesiologist, and there will be no intervention by the anesthesiologist performing the neurocognitive evaluation. Heart Rate, saturation, noninvasive arterial pressure values will be recorded upon entry and exit from the postoperative recovery unit. Postoperative pain monitoring will be done with Visual analog scala(VAS), and to patients with a Visual analog scala value above 3, Tramadol 100mg every 6 hours, Nonsteroidal anti-inflammatory 100mg every 6 hours, and paracetamol 1000mg every 6 hours will be given intravenously if necessary. MMDD test and Mini-cog test will be repeated in all patients by the anesthesiologist just before being transferred from the postoperative recovery unit to the ward and at the 24th hour, 3rd day, and 5th day postoperatively. After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, which anesthesia method was applied to the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total time and amount used will be recorded. Patients who underwent total intravenous anesthesia and inhaler anesthesia will be included in the study. Patients whose anesthesia management is changed during the case will be considered excluded from the study. Anesthesia management of patients during the preoperative and peroperative periods will be planned and implemented as deemed appropriate by the anesthesiologist who follows the patient during the surgery, regardless of this planned study. The researcher performing the neurocognitive evaluation will not have any intervention or knowledge in these processes. The reason why this study was planned as a prospective study is that neurocognitive evaluations are performed prospectively. There will be no intervention in the patient's preoperative, peroperative and postoperative anesthesia management. At the end of the study, the relationship between neurocognitive values and total intravenous anesthesia and inhaled anesthetics will be compared.

Conditions

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2024-11-12
• Primary completion: 2025-02-15
• Completion: 2025-05-15
• First posted: 2024-11-12
• Last updated: 2024-11-14

Locations

1 site across 1 country: Turkey (Türkiye)