The Effects of Dexmedetomidine on Postoperative Cognitive Function in Open Heart Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Neurologic Manifestations; Postoperative Cognitive Dysfunction; Cardiac Surgery
• Intervention / Treatment: Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B (Dexmedetomidine); Patients receive intravenous dexmedetomidine infusion during open-heart surgery in addition to standard anesthesia.	Drug: Dexmedetomidine; Dexmedetomidine infusion during open heart surgery; Other Names: Precedex
Placebo Comparator: Group A (control); Patients receive intravenous normal saline infusion during surgery as placebo control in addition to standard anesthesia.	Drug: Dexmedetomidine; Dexmedetomidine infusion during open heart surgery; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative cognitive function	Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE).	Preoperative baseline, and at 1 day, 3 days, and 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum neuron-specific enolase levels	Serum neuron-specific enolase levels will be measured as a biomarker of neuronal injury.	Preoperative baseline and 12 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bispectral index-guided anesthesia depth	Bispectral index monitoring will be used to assess intraoperative anesthesia depth.	At induction of anesthesia, immediately after intubation, at skin incision, during cardiopulmonary bypass, and at the end of surgery

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Salaheldin A Abdelaziz, MSc, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2023
• Primary Completion (Actual): September 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Dexmedetomidine; Cardiac Anesthesia; Neuron Specific Enolase
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Cognitive Complications; Neurologic Manifestations; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: Soh-Med-15-10-1MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No