NCT06689137

Effects of Dexmedetomidine on Postoperative Neurocognitive Disorder

Evaluation of the Effect of Dexmedetomidine Infusion on Postoperative Neurocognitive Disorder in Patients Undergoing Laparotomic Abdominal Surgery

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

Summary

This prospective study involves assessing neurocognitive function in patients undergoing laparotomic gastrointestinal surgery. Mini Mental state Assessment test and Mini-Cog tests will be conducted at multiple intervals preoperatively and postoperatively. Anesthesia management, vital signs, drug consumption, and blood gas values will be recorded throughout the surgery. After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, the levels of dexmedetomidine and remifentanyl consumed by the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total duration and amount used will be recorded. At the end of the study, the relationship between neurocognitive values and dexmedetomidine will be compared.

Detailed description

All results of laparotomic gastrointestinal surgery that meet the inclusion criteria of the preoperative anesthesia evaluation process will be determined, and the neurocognitive evaluations, mini mental state assessment test and Mini-cog test will be delivered to all these patients by the anesthesiologist doctor 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 midazolam. After patients are monitored with standard American Society of Anesthesia monitoring (Heart rate (HR), peripheral saturation, non-invasive artery pressure monitoring), patient state index(PSI), the first 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, and Sevoflurane anesthesia will be maintained at 1 Minimal alveolar concentration level as inhalation anesthesia. Patient state index value will be kept between 40-60%. During the peroperative period, non-invasive arterial pressure values, saturation values, heart rate, body temperature values will be recorded on the follow-up form as preoperative, at the beginning of the operation, at 30-minute intervals from the beginning of the operation, and before and after extubation at the end of the operation. If the anesthesiologist starts remifentanyl and dexmedetomidine infusion to the patients during the surgery, when it started and at what dose will be noted on the anesthesia chart. The anesthesiologist performing the neurocognitive evaluation will not be aware of this. The decision whether to start these medications will depend on the relevant anesthesiologist's decision regarding the patient's specific anesthesia management, regardless of the study. Heart rate, peripheral saturation, non-invasive artery pressure values will be recorded upon entering and exiting the postoperative recovery unit. The patients' total bleeding amount, amount and type of intravenous fluid administered, and blood gas values will be recorded throughout the surgery. Postoperative pain monitoring will be done with the Numerical Pain Rating Scale, and in patients with an Numerical pain rating scale score greater than 4, Tramadol will be given 100mg every 6 hours, Nonsteroidal anti-inflammatory 100mg every 8 hours, and paracetamol 1000mg every 6 hours will be given intravenously if necessary. Mini mental state assessment 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 postoperative day. After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, the levels of dexmedetomidine and remifentanyl consumed by the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total duration and amount used will be recorded. 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 surgical period, 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 prospectively is that neurocognitive evaluation will be performed prospectively for 1 week. There is no intervention in the patient's anesthesia management and medications, or in the grouping of patients and their treatment. At the end of the study, the relationship between neurocognitive values and dexmedetomidine will be compared.

Conditions

• Neurocognitive Disorder
• Dexmedetomidine Infusion
• Postoperative Cognitive Dysfunction
• Postoperative Cognitive Dysfunction(POCD)
• Laparoscopic Abdominal Surgery

Interventions

Type	Name	Description
OTHER	mini mental state assessment test	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. 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	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. In this study, the frequently used Mini mental state assessment test and 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: 2024-10-13
• Primary completion: 2025-03-15
• Completion: 2025-06-15
• First posted: 2024-11-14
• Last updated: 2024-11-14

Locations

1 site across 1 country: Turkey (Türkiye)