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

NCT06366412 | Recruiting Phase 4

• 1 other identifier: serum Tau-217 in elderly
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Impairment

Keywords

dexmedetomidine; serum Tau-217 protein; cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group.

  2 years

Other Outcomes (2)

• 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

  2 years

• 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

  2 years

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Will receive induction of general anesthesia by loading dose of dexmedetomidine (Precedex) 0.6 μg/kg over 10 minutes in a 20 ml micropump, fentanyl in a dose of 1 μg /kg, propofol 1-1.5 mg/kg, and endotracheal intubation will be facilitated by 0.5mg/kg of atracurium and maintenance of anesthesia will be achieved by dexmedetomidine in a dose of 0.3 μg/kg/hr on 50 ml micropump and isoflurane (1-2%) in oxygen-air mixture.

Drug: Dexmedetomidine Hydrochloride

Placebo group

PLACEBO COMPARATOR

Will receive induction of general anesthesia by infusion of normal saline 20 ml micropump over 10 min, fentanyl in a dose of 1 μg/kg, propofol 1-1.5 mg/kg and endotracheal intubation will be facilitated by 0.5mg/kg of atracurium and maintenance of anesthesia will be achieved by isoflurane (1-2%) in oxygen-air mixture and infusion of 50 ml/hr micropump of normal saline.

Other: normal saline

Interventions

Dexmedetomidine Hydrochloride DRUG

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

Also known as: precedex

Dexmedetomidine group

normal saline OTHER

normal saline will be administrated in placebo group

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University Hospital: lead

Study Sites (1)

Arwa Essam

Minya, 61111, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 34418401 BACKGROUND

• 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.

  PMID: 35465951 BACKGROUND

• 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.

  PMID: 33228978 BACKGROUND

• 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.

  PMID: 35794069 BACKGROUND

• 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.

  PMID: 35864562 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Arwa Essam Anwar, Assistant Lecturer

CONTACT

+201017565658; arwty26@gmail.com

Amr Nady Abd Elrazik, Assistant Lecturer

CONTACT

+201023451177

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 15, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

EG (1)