Post-cardiac SurgeryNCT06907277
Dexmedetomidine Enhancing the Recovery After Cardiac Surgery
A study testing Dexmedetomidine, Fentanyl and Lidocain in people with Post-cardiac Surgery, run by Benha University at 1 site in Egypt.
Trial summary
Enhanced Recovery After Surgery (ERAS) aims to facilitate a quicker and smoother recovery period following surgical procedures. The implementation of these protocols may lead to patients returning to their daily activities sooner, experiencing greater satisfaction with their care, and potentially encountering fewer… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- Dexmedetomidine, Fentanyl and Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2024to 31 Jan 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of American Society of Anesthesiologists Classification (ASA) grade II-III;
- Patients who were planned to have Coronary Artery Bypass Graft (CABG);
- Patients were free of exclusion criteria.
Who cannot join
- Patients with preoperative high risk for getting Post Operative Delirium or sleep disorders,
- Patients with American Society of Anesthesiologists Classification (ASA) grade>III;
- Patients with heart failure, left ventricle ejection fraction of <25%,
- Patients with uncontrolled diabetes mellitus, coagulopathy, or history of uncompensated renal or hepatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine-based Enhanced Recovery After Cardiac Surgery Improves Outcome Regarding Analgesia, Sleep Disorders, and Postoperative Delirium
Enhanced Recovery After Surgery (ERAS) aims to facilitate a quicker and smoother recovery period following surgical procedures. The implementation of these protocols may lead to patients returning to their daily activities sooner, experiencing greater satisfaction with their care, and potentially encountering fewer complications, ultimately contributing to shorter hospital stays. However, a common challenge in the postoperative phase is postoperative delirium(POD). This complication can lead to both immediate and long-term cognitive impairments, negatively impact overall health outcomes, and increase the financial burden on the healthcare system. Interestingly, dexmedetomidine, known as DXM, is a medication that selectively targets certain receptors in the brain and offers sedative properties with minimal impact on breathing. This characteristic is noteworthy because it may help regulate sleep patterns and support the preservation of cognitive function during the recovery period.
- Conditions
- Post-cardiac Surgery
- Being tested
- Dexmedetomidine, Fentanyl, Lidocain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine (DXM) loading dose of 0.6 µg/kg followed by DXM infusion given at a rate of 0.4 ml/kg/h and was provided as 0.15 µg/kg/h for 24-h PO.
FentanylDrug
A bolus of fentanyl 5 µg/kg followed by an intraoperative (IO) fentanyl infusion of 3-5 µg/kg/h that was continued as PO analgesia for 24 hours in a dose of 0.3 µg/kg/h.
LidocainDrug
Lidocaine (LID) loading dose (1 mg/kg) followed by a continuous infusion till 24 h PO as 1.5 mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | Not described Receives: Drug: Dexmedetomidine; Drug: Lidocain |
| Group F | Active comparator | Not described Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant Enhancement of Post Operative Recovery Levels After Dexmedetomidine Administration in Cardiac Surgery.
Post-operative recovery was measured on 3 levels: Confusion, Sleep Quality, and Delirium.
The study focused primarily on postoperative delirium through the Delirium Index, a 7-item questionnaire that graded the severity of delirium in patients with or without dementia. These seven items assess disorders of attention, thought, consciousness, orientation, memory, perception, and psychomotor activity. Each item is scored on a 0-3 scale, with zero indicating the absence of disturbance, while 1-3 indicates mild, moderate, and severe disturbance of the assessed function for a total score ranging between 0 and 21, and higher scores indicate higher delirium severity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start30 Aug 2024
- Primary completion1 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Benha 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd ElRahman Hammed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907277
- Sponsor's protocol ID
- RC 17-11-2024
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine-based Enhanced Recovery After Cardiac Surgery Improves Outcome Regarding Analgesia, Sleep Disorders, and Postoperative Delirium
- ClinicalTrials.gov ID
- NCT06907277
- Acronym / sponsor ID
- RC 17-11-2024
- Conditions
- Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 2 Apr 2025 (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.
Enhanced Recovery After Surgery (ERAS) aims to facilitate a quicker and smoother recovery period following surgical procedures. The implementation of these protocols may lead to patients returning to their daily activities sooner, experiencing greater satisfaction with their care, and potentially encountering fewer complications, ultimately contributing to shorter hospital stays. However, a common challenge in the postoperative phase is postoperative delirium(POD). This complication can lead to both immediate and long-term cognitive impairments, negatively impact overall health outcomes, and increase the financial burden on the healthcare system. Interestingly, dexmedetomidine, known as DXM, is a medication that selectively targets certain receptors in the brain and offers sedative properties with minimal impact on breathing. This characteristic is noteworthy because it may help regulate sleep patterns and support the preservation of cognitive function during the recovery period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: Dexmedetomidine, Drug: Lidocain |
| Group F | Active comparator | Drug: Fentanyl |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of American Society of Anesthesiologists Classification (ASA) grade II-III;
- Patients who were planned to have Coronary Artery Bypass Graft (CABG);
- Patients were free of exclusion criteria.
Key exclusion criteria (4 listed)
- Patients with preoperative high risk for getting Post Operative Delirium or sleep disorders,
- Patients with American Society of Anesthesiologists Classification (ASA) grade>III;
- Patients with heart failure, left ventricle ejection fraction of <25%,
- Patients with uncontrolled diabetes mellitus, coagulopathy, or history of uncompensated renal or hepatic diseases
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine (DXM) loading dose of 0.6 µg/kg followed by DXM infusion given at a rate of 0.4 ml/kg/h and was provided as 0.15 µg/kg/h for 24-h PO. | Drug | Group D |
| FentanylA bolus of fentanyl 5 µg/kg followed by an intraoperative (IO) fentanyl infusion of 3-5 µg/kg/h that was continued as PO analgesia for 24 hours in a dose of 0.3 µg/kg/h. | Drug | Group F |
| LidocainLidocaine (LID) loading dose (1 mg/kg) followed by a continuous infusion till 24 h PO as 1.5 mg/kg/h. | Drug | Group D |
Primary outcome
Significant Enhancement of Post Operative Recovery Levels After Dexmedetomidine Administration in Cardiac Surgery.
Time frame: 3 months
Post-operative recovery was measured on 3 levels: Confusion, Sleep Quality, and Delirium. The study focused primarily on postoperative delirium through the Delirium Index, a 7-item questionnaire that graded the severity of delirium in patients with or without dementia. These seven items assess disorders of attention, thought, consciousness, orientation, memory, perception, and psychomotor activity. Each item is scored on a 0-3 scale, with zero indicating the absence of disturbance, while 1-3 indicates mild, moderate, and severe disturbance of the assessed function for a total score ranging between 0 and 21, and higher scores indicate higher delirium severity.
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 2 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Fentanyl and Lidocain in people with Post-cardiac Surgery, run by Benha 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 3 inclusion and 4 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 2 Apr 2025. 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. 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?
Significant Enhancement of Post Operative Recovery Levels After Dexmedetomidine Administration in Cardiac Surgery. (time frame: 3 months). 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 2 Apr 2025.