Effects of Dexmedetomidine on Postoperative Neurocognitive Disorder

NCT06689137 | Active Not Recruiting

• 1 other identifier: HEA-AAR-MK-02
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

postoperative cognitive dysfunction; peroperative dexmedetomidine infusion; neurocognitive disorder

Outcome Measures

Primary Outcomes (1)

• Decrease in Mini Mental State Assessment test

  Patients who will undergo laparotomic lower and upper gastrointestinal system 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)

• Decrease in 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)

with dexmedetomidine group

In this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo laparotomic lower and upper gastrointestinal system surgery. 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 dexmedetomidine, remifentanyl consumed in this group will be recorded.

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

without dexmedetomidine group

In this study, pre- and postoperative neurological evaluation tests will be performed on patients who will undergo laparotomic lower and upper gastrointestinal system surgery. All patients will be monitored during the perioperative period according to the standards specified in the American Society of Anesthesiologists guide. Neurological evaluations will be performed 24 hours before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who did not receive dexmedetomidine infusion during peroperative anesthesia management will constitute this group. The total amounts of and remifentanyl consumed in this group will be recorded.

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

Interventions

mini mental state assessment test OTHER

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.

Also known as: neurocognitive disorder assessment

with dexmedetomidine group; without dexmedetomidine group

mini-cog test OTHER

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.

Also known as: neurocognitive disorder assessment

with dexmedetomidine group; without dexmedetomidine group

Eligibility Criteria

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

Study Population

Patients who will undergo laparotomic lower and upper abdominal surgery will constitute the patient groups of this study. Patients who will be operated on due to early stage gastrointestinal tumor will constitute the study population. Among these patients, those without neurological disorders will be included in the study.

You may qualify if:

• Patients aged 18-65 who will undergo laparotomic lower and upper gastrointestinal system surgery

You may not qualify if:

• American society of anesthesia of 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 whose 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34265, Turkey (Türkiye)

Location

Related Publications (2)

• Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.

  PMID: 18499604 BACKGROUND

• Maldonado JR, Wysong A, van der Starre PJ, Block T, Miller C, Reitz BA. Dexmedetomidine and the reduction of postoperative delirium after cardiac surgery. Psychosomatics. 2009 May-Jun;50(3):206-17. doi: 10.1176/appi.psy.50.3.206.

  PMID: 19567759 BACKGROUND

MeSH Terms

Conditions

Neurocognitive Disorders; Postoperative Cognitive Complications

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Munevver Kayhan, Medical 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: Specialist Doctor, Anesthesiologist

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: October 13, 2024
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)