Cardiac SurgeryNCT06655025
The Effects of Dexmedetomidine on Postoperative Cognitive Function in Open Heart Surgery
A study testing Dexmedetomidine in people with Cardiac Surgery and Postoperative Cognitive Dysfunction, run by Sohag University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery, Postoperative Cognitive Dysfunction, Neurologic Manifestations
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2023to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes undergoing elective open-heart surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Cardiac Anesthesia, Neuron Specific Enolase, Randomized Controlled Trial
- Medical subject headings
- Postoperative Cognitive Complications, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine infusion during open heart surgery
| Study group | Role | What they receive |
|---|---|---|
| Group B (Dexmedetomidine) | Active comparator | Patients receive intravenous dexmedetomidine infusion during open-heart surgery in addition to standard anesthesia. Receives: Drug: Dexmedetomidine |
| Group A (control) | Placebo comparator | Patients receive intravenous normal saline infusion during surgery as placebo control in addition to standard anesthesia. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum neuron-specific enolase levels
Serum neuron-specific enolase levels will be measured as a biomarker of neuronal injury.
Measured: Preoperative baseline and 12 hours after surgery
Secondary outcomes (1)
Postoperative cognitive function
Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE).
Measured: Preoperative baseline, and at 1 day, 3 days, and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start8 Oct 2023
- Primary completion8 Sep 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salaheldin Ahmed Abdelziz, Sohag University
- Investigators
- Salaheldin A Abdelaziz, MSc, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655025
- Sponsor's protocol ID
- Soh-Med-15-10-1MD
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on Postoperative Cognitive Function and Neuron-Specific Enolase Levels in Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06655025
- Acronym / sponsor ID
- Soh-Med-15-10-1MD
- Keywords
- Dexmedetomidine, Cardiac Anesthesia, Neuron Specific Enolase, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 8 Sep 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group B (Dexmedetomidine) | Active comparator | Drug: DexmedetomidinePatients receive intravenous dexmedetomidine infusion during open-heart surgery in addition to standard anesthesia. |
| Group A (control) | Placebo comparator | Drug: DexmedetomidinePatients receive intravenous normal saline infusion during surgery as placebo control in addition to standard anesthesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes undergoing elective open-heart surgery
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine infusion during open heart surgery | Drug | Group A (control), Group B (Dexmedetomidine) |
Primary outcome
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.
1 secondary outcome
Postoperative cognitive function
Time frame: Preoperative baseline, and at 1 day, 3 days, and 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salaheldin A Abdelaziz, MSc principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Cardiac Surgery and Postoperative Cognitive Dysfunction, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum neuron-specific enolase levels (time frame: Preoperative baseline and 12 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.