Morphine, Midazolam and Dexmedetomidine in the Management of Acute Cardiogenic Pulmonary Edema, Safety and Efficacy

NCT06653244 | Completed Phase 1

• 1 other identifier: 32024ANET10
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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 ventilation (NIV) and vasodilators constitute the key armamentarium for the initial treatment.

Conditions

Sedative Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Clinical improvement in length of hospital stay

  48 hours

Secondary Outcomes (2)

• In- hospital all- cause mortality.

  72 hours

• mortality

  30-day

Study Arms (3)

group Midazolam

ACTIVE COMPARATOR

midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) on demand

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

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

Drug: Injection

Interventions

Injection DRUG

dexmedimidine infusion

Also known as: morphine injection, midazolam injection

GROUP Morphine; Group Dexmedetomidine; group Midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menofia university

Shibīn al Kawm, Menofia, Egypt

Location

MeSH Terms

Interventions

Injections; Morphine; Midazolam

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive care

Model Details: 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

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 22, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 20, 2024
• Last Updated: June 26, 2025

Record last verified: 2024-10

Locations

EG (1)