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Clinical Trials/NCT06655025
NCT06655025
Completed
Not Applicable

The Effects of Dexmedetomidine on Postoperative Cognitive Function and Neuron-Specific Enolase Levels in Open Heart Surgery

Sohag University1 site in 1 country32 target enrollmentOctober 8, 2023
InterventionsDexmedetomidine

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Not specified
Sponsor
Sohag University
Enrollment
32
Locations
1
Primary Endpoint
Postoperative cognitive function
Status
Completed
Last Updated
last month

Overview

Brief Summary

To assess the impact of Dexmedetomidine on postoperative cognitive function and serum Neuron Specific Enolase levels as an indicator of neuronal injury in patients undergoing open heart surgery

Detailed Description

This randomized controlled study was conducted to evaluate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing elective open-heart surgery. Patients were randomly assigned into two groups: a dexmedetomidine group receiving intravenous dexmedetomidine infusion during surgery and a control group receiving normal saline infusion as placebo in addition to standard anesthesia. Postoperative cognitive function was assessed using the Mini-Mental State Examination (MMSE). Serum neuron-specific enolase (NSE) levels were measured as a biomarker of neuronal injury. Intraoperative depth of anesthesia was monitored using the bispectral index (BIS). The aim of the study was to investigate whether dexmedetomidine administration could reduce postoperative cognitive dysfunction and neuronal injury in patients undergoing cardiac surgery.

Registry
clinicaltrials.gov
Start Date
October 8, 2023
End Date
October 8, 2024
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Salaheldin Ahmed Abdelziz

specialist

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Patients of both sexes undergoing elective open-heart surgery

Exclusion Criteria

  • Patients with a history of neurological disorders, severe renal or liver dysfunction, or contraindications to Dexmedetomidine as in patients with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia, or hypomagnesemia, and in patients receiving other drugs known to prolong the QT interval.
  • Patients with cognitive impairment, mental and psychological illness and chronic alcoholics, drug addicts, abuse of psychotropic substances, illiterate education

Arms & Interventions

Group B (Dexmedetomidine)

Patients receive intravenous dexmedetomidine infusion during open-heart surgery in addition to standard anesthesia.

Intervention: Dexmedetomidine

Group A (control)

Patients receive intravenous normal saline infusion during surgery as placebo control in addition to standard anesthesia.

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

Postoperative cognitive function

Time Frame: Preoperative baseline, and at 1 day, 3 days, and 7 days after surgery

Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE).

Secondary Outcomes

  • Serum neuron-specific enolase levels(Preoperative baseline and 12 hours after surgery)

Study Sites (1)

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