NCT06653244

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Injection	dexmedimidine infusion

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-12-01
• Completion: 2024-12-20
• First posted: 2024-10-22
• Last updated: 2025-06-26

Locations

1 site across 1 country: Egypt