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

NCT06655025 | Completed

• 1 other identifier: Soh-Med-15-10-1MD
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Surgery; Postoperative Cognitive Dysfunction; Neurologic Manifestations

Keywords

Dexmedetomidine; Cardiac Anesthesia; Neuron Specific Enolase; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum neuron-specific enolase levels

  Preoperative baseline and 12 hours after surgery

Other Outcomes (1)

• Bispectral index-guided anesthesia depth

  At induction of anesthesia, immediately after intubation, at skin incision, during cardiopulmonary bypass, and at the end of surgery

Study Arms (2)

Group B (Dexmedetomidine)

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Group A (control)

PLACEBO COMPARATOR

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

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine infusion during open heart surgery

Also known as: Precedex

Group A (control); Group B (Dexmedetomidine)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes undergoing elective open-heart surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Neurologic Manifestations

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Salaheldin A Abdelaziz, MSc

  Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcome assessors were blinded to group allocation. Dexmedetomidine and placebo solutions were prepared in identical syringes by an independent anesthesiologist not involved in patient management or data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Model Details: Patients undergoing elective open-heart surgery were randomly assigned in a 1:1 ratio to receive either dexmedetomidine infusion or placebo (normal saline) during surgery.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 8, 2023
• Primary Completion: September 8, 2024
• Study Completion: October 8, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)