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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine group

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.

Group Type EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type DRUG

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

Placebo group

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

normal saline will be administrated in placebo group

Interventions

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Dexmedetomidine Hydrochloride

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

Intervention Type DRUG

normal saline

normal saline will be administrated in placebo group

Intervention Type OTHER

Other Intervention Names

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precedex

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes