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

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.

Study Overview

• Status: Completed
• Conditions: Sedative Adverse Reaction
• Intervention / Treatment: Drug: Injection

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Menofia
    • Shibīn Al Kawm, Menofia, Egypt
      • Menofia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group Midazolam; midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) on demand	Drug: Injection; dexmedimidine infusion; Other Names: morphine injection; midazolam injection
Active Comparator: GROUP Morphine; morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg every 12 hours	Drug: Injection; dexmedimidine infusion; Other Names: morphine injection; midazolam injection
Active Comparator: Group Dexmedetomidine; 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; dexmedimidine infusion; Other Names: morphine injection; midazolam injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical improvement in length of hospital stay	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	30-day
In- hospital all- cause mortality.	72 hours

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 20, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Morphine; Midazolam
• Other Study ID Numbers: 32024ANET10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No