Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein.

Cognitive Impairment Clinical Trial

Official title:

Effect of Dexmedetomidine on Serum Tau-217 Protein as a Biomarker for Post-operative Cognitive Dysfunction in Elderly Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366412
• Other study ID #: serum Tau-217 in elderly
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Minia University Hospital
• Contact: Arwa Essam Anwar, Assistant Lecturer
• Phone: +201017565658
• Email: arwty26[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia.

Description:

to assess the effect of dexmedetomidine on serum Tau-217 protein through measuring serum Tau-217 protein preoperative and postoperative period and comparing the 2 measurements , assessing the cognitive dysfunction in the elderly patients and comparing the correlation between the cognitive dysfunction with serum tau-217 level also assessing the neuroprotective effect of dexmedetomidine on postoperative cognitive dysfunction and its relation with serum Tau-217 level.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients aged > 65 years old, both genders, Basal Metabolic Index range 18.5 to less than 35 American Society of Anesthesiologists I - III with Glasgow Coma Scale 14-15 undergoing major surgery under general anesthesia.

Exclusion Criteria:

• Patients will be excluded if they refused the enrollment in our study, Glasgow Coma Scale<14 or if there is severe cardiac, liver or renal disease, patients have Alzehimer's Disease or any of the psychotic diseases, poorly educated patients and if there is any sensitivity to given drugs

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Drug:
• Dexmedetomidine Hydrochloride
dexmedetomidine effect in preventing postoperative cognitive dysfunction on elderly patients undergoing major surgery guided with serum Tau-217 protein.

Other:
• normal saline
normal saline will be administrated in placebo group

Locations

Country	Name	City	State
Egypt	Arwa Essam	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Ballweg T, White M, Parker M, Casey C, Bo A, Farahbakhsh Z, Kayser A, Blair A, Lindroth H, Pearce RA, Blennow K, Zetterberg H, Lennertz R, Sanders RD. Association between plasma tau and postoperative delirium incidence and severity: a prospective observational study. Br J Anaesth. 2021 Feb;126(2):458-466. doi: 10.1016/j.bja.2020.08.061. Epub 2020 Nov 20. — View Citation

Liang F, Baldyga K, Quan Q, Khatri A, Choi S, Wiener-Kronish J, Akeju O, Westover MB, Cody K, Shen Y, Marcantonio ER, Xie Z. Preoperative Plasma Tau-PT217 and Tau-PT181 Are Associated With Postoperative Delirium. Ann Surg. 2023 Jun 1;277(6):e1232-e1238. doi: 10.1097/SLA.0000000000005487. Epub 2022 Jul 6. — View Citation

McKay TB, Qu J, Liang F, Mueller A, Wiener-Kronish J, Xie Z, Akeju O. Tau as a serum biomarker of delirium after major cardiac surgery: a single centre case-control study. Br J Anaesth. 2022 Jul;129(1):e13-e16. doi: 10.1016/j.bja.2022.04.002. Epub 2022 Apr 22. No abstract available. — View Citation

Thijssen EH, La Joie R, Strom A, Fonseca C, Iaccarino L, Wolf A, Spina S, Allen IE, Cobigo Y, Heuer H, VandeVrede L, Proctor NK, Lago AL, Baker S, Sivasankaran R, Kieloch A, Kinhikar A, Yu L, Valentin MA, Jeromin A, Zetterberg H, Hansson O, Mattsson-Carlgren N, Graham D, Blennow K, Kramer JH, Grinberg LT, Seeley WW, Rosen H, Boeve BF, Miller BL, Teunissen CE, Rabinovici GD, Rojas JC, Dage JL, Boxer AL; Advancing Research and Treatment for Frontotemporal Lobar Degeneration investigators. Plasma phosphorylated tau 217 and phosphorylated tau 181 as biomarkers in Alzheimer's disease and frontotemporal lobar degeneration: a retrospective diagnostic performance study. Lancet Neurol. 2021 Sep;20(9):739-752. doi: 10.1016/S1474-4422(21)00214-3. Erratum In: Lancet Neurol. 2021 Oct;20(10):e6. — View Citation

Wang W, Ma Y, Liu Y, Wang P, Liu Y. Effects of Dexmedetomidine Anesthesia on Early Postoperative Cognitive Dysfunction in Elderly Patients. ACS Chem Neurosci. 2022 Aug 3;13(15):2309-2314. doi: 10.1021/acschemneuro.2c00173. Epub 2022 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours	Heart Rate will be measured in beat/min	2 years
Other	Mean Arterial Blood Pressure changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours	Mean Arterial Blood Pressure will be measured in mmHg/min	2 years
Primary	the effect of dexmedetomidine on serum Tau-217 protein value.	estimation of the effect of dexmedetomidine on serum Tau-217 protein in postoperative period.	2 years
Secondary	to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group.	evaluation of the postoperative cognitive dysfunction by Mini Mental State Scale as >25 is recorded normal while less than <24 is positive for cognitive dysfunction.	2 years