Sedative Adverse ReactionPhase 1NCT06653244
Morphine, Midazolam and Dexmedetomidine in the Management of Acute Cardiogenic Pulmonary Edema, Safety and Efficacy
A Phase 1 study testing Injection in people with Sedative Adverse Reaction, run by Menoufia University at 1 site in Egypt.
Trial summary
Acute cardiogenic pulmonary edema is a stressful scenario with progressive respiratory failure that may lead to cardiorespiratory collapse within hours, or minutes unless therapeutic action is taken As the initial events in involve hemodynamic pulmonary congestion with high capillary pressures, diuretics, non-invasive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sedative Adverse Reaction
- What is being tested?
- Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 20 Dec 2024
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 year with a clinical diagnosis of ACPE with severe dyspnea and anxiety.
- Patients able to verbally acknowledge the risks in receiving midazolam, morphine or dexmedetomidine.-
- Diagnosis of ACPE was defined by the association of sudden onset of dyspnoea, the presence of bilateral rales on auscultation, respiratory rate >25 breaths/min and pulse oxygen saturation <90% in room air. diagnosis will be confirmed by echocardiography and lung ultrasound
Who cannot join
- Patients with history of asthma, severe stenotic valvular disease. • Cardiovascular collapse or an impaired level of consciousness (Glasgow Coma Scale score of ≤8 points).
- Immediate indication for intubation.
- Suspicion of ST-segment elevation, acute coronary syndrome needing interventions.
- Known severe liver or renal disease, pneumonia, poor chance of survival due to a pre-existing condition.
- Psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Acute cardiogenic pulmonary edema is a stressful scenario with progressive respiratory failure that may lead to cardiorespiratory collapse within hours, or minutes unless therapeutic action is taken As the initial events in involve hemodynamic pulmonary congestion with high capillary pressures, diuretics, non-invasive ventilation (NIV) and vasodilators constitute the key armamentarium for the initial treatment.
Read the detailed description
The patients will be randomized in a 1:1:1 ratio, (group midazolam i) midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) (group morphine) morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg [14], [15],(group Dexmedetomidine.) dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr
- Boluses of morphine, midazolam and dexmeddetomidine will be repeated on demand according to Ramsay sedation scale.
- All patients will be assessed for need of noninvasive ventilation by total face mask connected to ventilator.
- Medical therapy with intravenous boluses of loop diuretics, intravenous infusions of nitroglycerine, oxygen supplementation will be provided by physicians according to their clinical judgment
- The target in all patients is to provide anxiolytic or light sedation effect for good compliance to noninvasive ventilation and reducing of pulmonary congestion.
- The expected sedation scores (Ramsay score 2-3) will be achieved in all of the patients taking morphine, midazolam or dexmedetomidine
- Conditions
- Sedative Adverse Reaction
- Being tested
- Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectionDrug
Also called morphine injection, midazolam injection
dexmedimidine infusion
| Study group | Role | What they receive |
|---|---|---|
| group Midazolam | Active comparator | midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) on demand Receives: Drug: Injection |
| GROUP Morphine | Active comparator | morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg every 12 hours Receives: Drug: Injection |
| Group Dexmedetomidine | Active comparator | dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV 7 infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr Receives: Drug: Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement in length of hospital stay
Measured: 48 hours
Secondary outcomes (2)
In- hospital all- cause mortality.
Measured: 72 hours
mortality
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Apr 2024
- Primary completion1 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Menoufia 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The patients will be randomized in a 1:1:1 ratio, (group Mi) midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) \[14\], \[15\],(group Mo) morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg \[14\], \[15\],(group Dex.) dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV 7 infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Said Abdel Haleem, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653244
- Sponsor's protocol ID
- 32024ANET10
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine, Midazolam and Dexmedetomidine in the Management of Acute Cardiogenic Pulmonary Edema, Safety and Efficacy
- ClinicalTrials.gov ID
- NCT06653244
- Acronym / sponsor ID
- 32024ANET10
- Conditions
- Sedative Adverse Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 22 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.
Acute cardiogenic pulmonary edema is a stressful scenario with progressive respiratory failure that may lead to cardiorespiratory collapse within hours, or minutes unless therapeutic action is taken As the initial events in involve hemodynamic pulmonary congestion with high capillary pressures, diuretics, non-invasive ventilation (NIV) and vasodilators constitute the key armamentarium for the initial treatment.
Detailed description
The patients will be randomized in a 1:1:1 ratio, (group midazolam i) midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) (group morphine) morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg [14], [15],(group Dexmedetomidine.) dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr
- Boluses of morphine, midazolam and dexmeddetomidine will be repeated on demand according to Ramsay sedation scale.
- All patients will be assessed for need of noninvasive ventilation by total face mask connected to ventilator.
- Medical therapy with intravenous boluses of loop diuretics, intravenous infusions of nitroglycerine, oxygen supplementation will be provided by physicians according to their clinical judgment
- The target in all patients is to provide anxiolytic or light sedation effect for good compliance to noninvasive ventilation and reducing of pulmonary congestion.
- The expected sedation scores (Ramsay score 2-3) will be achieved in all of the patients taking morphine, midazolam or dexmedetomidine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The patients will be randomized in a 1:1:1 ratio, (group Mi) midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) [14], [15],(group Mo) morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg [14], [15],(group Dex.) dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV 7 infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr
| Arm | Type | Receives |
|---|---|---|
| group Midazolam | Active comparator | Drug: Injectionmidazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) on demand |
| GROUP Morphine | Active comparator | Drug: Injectionmorphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg every 12 hours |
| Group Dexmedetomidine | Active comparator | Drug: Injectiondexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV 7 infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 year with a clinical diagnosis of ACPE with severe dyspnea and anxiety.
- Patients able to verbally acknowledge the risks in receiving midazolam, morphine or dexmedetomidine.-
- Diagnosis of ACPE was defined by the association of sudden onset of dyspnoea, the presence of bilateral rales on auscultation, respiratory rate >25 breaths/min and pulse oxygen saturation <90% in room air. diagnosis will be confirmed by echocardiography and lung ultrasound
Key exclusion criteria (5 listed)
- Patients with history of asthma, severe stenotic valvular disease. • Cardiovascular collapse or an impaired level of consciousness (Glasgow Coma Scale score of ≤8 points).
- Immediate indication for intubation.
- Suspicion of ST-segment elevation, acute coronary syndrome needing interventions.
- Known severe liver or renal disease, pneumonia, poor chance of survival due to a pre-existing condition.
- Psychiatric disorders.
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 |
|---|---|---|
| InjectionAlso: morphine injection, midazolam injectiondexmedimidine infusion | Drug | GROUP Morphine, Group Dexmedetomidine, group Midazolam |
Primary outcome
Clinical improvement in length of hospital stay
Time frame: 48 hours
2 secondary outcomes
In- hospital all- cause mortality.
Time frame: 72 hours
mortality
Time frame: 30-day
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 26 Jun 2025.
Related trials for Sedative Adverse Reaction
Not yet recruitingObservational study
Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study
Circadian Rhythm, Ciprofol
RecruitingPhase 4
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Ketamine Adverse Reaction
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 Phase 1 study testing Injection in people with Sedative Adverse Reaction, run by Menoufia 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 5 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 26 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical improvement in length of hospital stay (time frame: 48 hours). 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 26 Jun 2025.