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

April 12, 2024 updated by: Arwa Essam, Minia University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Arwa Essam Anwar, Assistant Lecturer
  • Phone Number: +201017565658
  • Email: arwty26@gmail.com

Study Contact Backup

  • Name: Amr Nady Abd Elrazik, Assistant Lecturer
  • Phone Number: +201023451177

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Recruiting
        • Arwa Essam
        • Contact:
          • Arwa essam Essam, assistant lecturer
          • Phone Number: +201017565658
          • Email: arwty26@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Dexmedetomidine Hydrochloride
dexmedetomidine effect in preventing postoperative cognitive dysfunction on elderly patients undergoing major surgery guided with serum Tau-217 protein.
Other Names:
  • precedex
Placebo Comparator: 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.
Other: normal saline
normal saline will be administrated in placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect of dexmedetomidine on serum Tau-217 protein value.
Time Frame: 2 years
estimation of the effect of dexmedetomidine on serum Tau-217 protein in postoperative period.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group.
Time Frame: 2 years
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 2 years
Heart Rate will be measured in beat/min
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
Time Frame: 2 years
Mean Arterial Blood Pressure will be measured in mmHg/min
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • serum Tau-217 in elderly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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