Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653244
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Morphine Midazolam and Dexmedetomidine in the Management of Acute Cardiogenic Pulmonary Edema Safety and Efficacy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Morphine Midazolam and Dexmedetomidine in the Management of Acute Cardiogenic Pulmonary Edema Safety and Efficacy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The patients will be randomized in a 111 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 15group Dexmedetomidine dexmedetomidine administered intravenously Load 025 mcgkg IV over 10 minutes Maintenance 02-07 mcgkghr 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None