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NCT Number: NCT06655025

The Effects of Dexmedetomidine on Postoperative Cognitive Function 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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine infusion during open heart surgery

Other names: Precedex

Primary outcomes

  1. 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

  1. Serum neuron-specific enolase levels

    Time frame: Preoperative baseline and 12 hours after surgery

    Serum neuron-specific enolase levels will be measured as a biomarker of neuronal injury.

Other outcomes

  1. Bispectral index-guided anesthesia depth

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

    Bispectral index monitoring will be used to assess intraoperative anesthesia depth.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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