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

Minia University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Cognitive Impairment

Treatments: Other: normal saline; Drug: Dexmedetomidine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06366412

serum Tau-217 in elderly

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine Hydrochloride

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Other: normal saline