Delirium - PostoperativeEarly Phase 1NCT06756178
Effect of Remimazolam Versus Dexmedetomidine on the Incidence of Delirium After Elective Cardiac Surgery with Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial
A Early Phase 1 study testing Propofol Group 1, Remimazolam Intervention and Dexmedetomidine Intervention in people with Delirium - Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
The study aims to improve the post-open heart surgery lifestyle and overall experience, as well as assess the incidence of delirium using Remimazolam and Dexmedetomidine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium - Postoperative
- What is being tested?
- Propofol Group 1, Remimazolam Intervention and Dexmedetomidine Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 1 Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Scheduled for cardiac surgery (CABG and/or valve replacement).
- Elective surgery
Who cannot join
- Patients with known allergies to Remimazolam or Dexmedetomidine
- Refusal to participate.
- History of psychiatric or neurological conditions (schizophrenia, epilepsy, severe dementia, etc.).
- Preoperative inability to communicate (severe visual/auditory dysfunction, language barriers).
- Severe hepatic or renal dysfunction
- Cardiopulmonary bypass time not ≥ 120 minutes
Show all 10Show fewer
- aortic clamping time not ≥ 90 minutes
- Emergency surgeries
- On preoperative mechanical ventilation and long sedation time
- reoperated patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The study aims to improve the post-open heart surgery lifestyle and overall experience, as well as assess the incidence of delirium using Remimazolam and Dexmedetomidine.
Read the detailed description
Delirium is an acute brain dysfunction characterized by an acute onset and fluctuating course of disturbance in attention, awareness, and cognition, It is the most common neurocognitive complication following cardiac surgery, with an incidence rate between 11% and 52%.
The occurrence of delirium correlates strongly with various short- and long-term poor outcomes following cardiac surgery, including prolonged ICU stay and hospitalization and increased risk of hospital readmission. Different risk factors contribute to delirium after cardiac surgery, including advanced age, pre-existing cognitive impairment, diabetes, history of stroke, type of surgery, extended CPB duration, and blood transfusion. Dexmedetomidine is a highly and potently selective α2-adrenoceptor agonist with anxiolytic, sedative, and analgesic properties. It has neuroprotective effects by reducing neuroinflammation, apoptosis, and blood-brain barrier injury via central α2A adrenoceptors, but it can cause hypotension and bradycardia.
Remimazolam, a new ultra-short-acting benzodiazepine, also has a faster onset of action and a higher safety profile. It was recently approved for procedural sedation and general anesthesia. Its metabolism is mainly induced by tissue esterase, independent of liver and kidney function, and its metabolites are inactive. In addition, flumazenil reverses the effects of Remimazolam in the event of adverse events, an advantage not available in non-benzodiazepines. The objective of this clinical trial is to evaluate the efficacy of Remimazolam compared with Dexmedetomidine for preventing postoperative delirium after cardiac surgery.
- Conditions
- Delirium - Postoperative
- Being tested
- Propofol Group 1, Remimazolam Intervention, Dexmedetomidine Intervention
- Keywords
- cradiac surgery with cardiopulmonary bypass
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol Group 1Drug
Postoperative Use:
Bolus: 10-20 mg intravenously as needed for sedation initiation. Continuous infusion: 0.3-0.5 mg/kg/hour to maintain light sedation adjusted based on clinical response.
Remimazolam InterventionDrug
Postoperative Use:
Initial bolus: 5 mg intravenously upon ICU arrival. Continuous infusion: 0.2-0.3 mg/kg/hour to maintain light sedation with a maximum dose of 0.8 mg/kg/hour.
Rescue sedation with propofol or midazolam will be allowed if patients become agitated or if Remimazolam is ineffective in maintaining target sedation.
Dexmedetomidine InterventionDrug
Postoperative Use:
Loading dose: 0.5-1 μg/kg over 10-20 minutes after ICU arrival. Continuous infusion: 0.2-0.7 μg/kg/hour for sedation maintenance, adjusted as needed to maintain light sedation.
Rescue sedation with propofol or midazolam will be administered if Dexmedetomidine fails to maintain adequate sedation or if patients become agitated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : propofol group | Placebo comparator | Postoperative Use Receives: Drug: Propofol Group 1 |
| Group 2: Remimazolam Intervention | Experimental | Postoperative Use Receives: Drug: Remimazolam Intervention |
| Group 3: Dexmedetomidine Intervention | Experimental | Postoperative Use Receives: Drug: Dexmedetomidine Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium (POD)
Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first 5 days after surgery
Measured: During the first 5 days after surgery
Secondary outcomes (1)
Time of delirium onset and duration ,Sedation level
- Time of delirium onset and duration until the end of it.
- Sedation level: Assessed using the Richmond Agitation-Sedation Scale (RASS).
Measured: During first 5 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 posted1 Jan 2025
- Study start10 Jan 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effect of Remimazolam versus Dexmedetomidine on the incidence of delirium post elective cardiac suregery
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moataz Emad Eldin Omar Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756178
- Sponsor's protocol ID
- Elective cardiac surgery
- Status last verified
- Nov 2024
- First submitted
- 17 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam Versus Dexmedetomidine on the Incidence of Delirium After Elective Cardiac Surgery with Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06756178
- Acronym / sponsor ID
- Elective cardiac surgery
- Conditions
- Delirium - Postoperative
- Keywords
- cradiac surgery with cardiopulmonary bypass
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 1 Jan 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.
The study aims to improve the post-open heart surgery lifestyle and overall experience, as well as assess the incidence of delirium using Remimazolam and Dexmedetomidine.
Detailed description
Delirium is an acute brain dysfunction characterized by an acute onset and fluctuating course of disturbance in attention, awareness, and cognition, It is the most common neurocognitive complication following cardiac surgery, with an incidence rate between 11% and 52%.
The occurrence of delirium correlates strongly with various short- and long-term poor outcomes following cardiac surgery, including prolonged ICU stay and hospitalization and increased risk of hospital readmission. Different risk factors contribute to delirium after cardiac surgery, including advanced age, pre-existing cognitive impairment, diabetes, history of stroke, type of surgery, extended CPB duration, and blood transfusion. Dexmedetomidine is a highly and potently selective α2-adrenoceptor agonist with anxiolytic, sedative, and analgesic properties. It has neuroprotective effects by reducing neuroinflammation, apoptosis, and blood-brain barrier injury via central α2A adrenoceptors, but it can cause hypotension and bradycardia.
Remimazolam, a new ultra-short-acting benzodiazepine, also has a faster onset of action and a higher safety profile. It was recently approved for procedural sedation and general anesthesia. Its metabolism is mainly induced by tissue esterase, independent of liver and kidney function, and its metabolites are inactive. In addition, flumazenil reverses the effects of Remimazolam in the event of adverse events, an advantage not available in non-benzodiazepines. The objective of this clinical trial is to evaluate the efficacy of Remimazolam compared with Dexmedetomidine for preventing postoperative delirium after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Effect of Remimazolam versus Dexmedetomidine on the incidence of delirium post elective cardiac suregery
| Arm | Type | Receives |
|---|---|---|
| Group 1 : propofol group | Placebo comparator | Drug: Propofol Group 1Postoperative Use |
| Group 2: Remimazolam Intervention | Experimental | Drug: Remimazolam InterventionPostoperative Use |
| Group 3: Dexmedetomidine Intervention | Experimental | Drug: Dexmedetomidine InterventionPostoperative Use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Scheduled for cardiac surgery (CABG and/or valve replacement).
- Elective surgery
Key exclusion criteria (10 listed)
- Patients with known allergies to Remimazolam or Dexmedetomidine
- Refusal to participate.
- History of psychiatric or neurological conditions (schizophrenia, epilepsy, severe dementia, etc.).
- Preoperative inability to communicate (severe visual/auditory dysfunction, language barriers).
- Severe hepatic or renal dysfunction
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 |
|---|---|---|
| Propofol Group 1Postoperative Use: Bolus: 10-20 mg intravenously as needed for sedation initiation. Continuous infusion: 0.3-0.5 mg/kg/hour to maintain light sedation adjusted based on clinical response. | Drug | Group 1 : propofol group |
| Remimazolam InterventionPostoperative Use: Initial bolus: 5 mg intravenously upon ICU arrival. Continuous infusion: 0.2-0.3 mg/kg/hour to maintain light sedation with a maximum dose of 0.8 mg/kg/hour. Rescue sedation with propofol or midazolam will be allowed if patients become agitated or if Remimazolam is ineffective in maintaining target sedation. | Drug | Group 2: Remimazolam Intervention |
| Dexmedetomidine InterventionPostoperative Use: Loading dose: 0.5-1 μg/kg over 10-20 minutes after ICU arrival. Continuous infusion: 0.2-0.7 μg/kg/hour for sedation maintenance, adjusted as needed to maintain light sedation. Rescue sedation with propofol or midazolam will be administered if Dexmedetomidine fails to maintain adequate sedation or if patients become agitated. | Drug | Group 3: Dexmedetomidine Intervention |
Primary outcome
Postoperative Delirium (POD)
Time frame: During the first 5 days after surgery
Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first 5 days after surgery
1 secondary outcome
Time of delirium onset and duration ,Sedation level
Time frame: During first 5 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- The effect of perioperative dexmedetomidine on postoperative delirium in adult patients undergoing cardiac surgery with cardiopulmonary bypassLink provided by the sponsor.
- Clinical Pharmacokinetics and Pharmacodynamics of DexmedetomidineLink provided by the sponsor.
- The neuroprotective effect of dexmedetomidine and its mechanismLink provided by the sponsor.
- Remimazolam: First ApprovalLink provided by the sponsor.
- Remimazolam besilate, a benzodiazepine, has been approved for general anesthesiaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propofol Group 1, Remimazolam Intervention and Dexmedetomidine Intervention in people with Delirium - Postoperative, run by Assiut 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 10 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: opening soon, as of the sponsor's last update on 1 Jan 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moataz Emad Omar, Assistant lecturer (+2001011990789, moataz.emad90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (POD) (time frame: During the first 5 days 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 1 Jan 2025.