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Completed

NCT Number: NCT06653244

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Menofia university

Shibīn al Kawm, Menofia, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Injection

Drug

dexmedimidine infusion

Other names: morphine injection, midazolam injection

Primary outcomes

  1. Clinical improvement in length of hospital stay

    Time frame: 48 hours

Secondary outcomes

  1. In- hospital all- cause mortality.

    Time frame: 72 hours

  2. mortality

    Time frame: 30-day

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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