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Clinical trial

Comparative Study Between Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation After Adult Valvular Cardiac Surgeries; a Prospective Randomized Blinded Clinical Trial

ID
Name
Anesth-._098/2023
Description
Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery. It facilitates the patient's unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery, intubation, mechanical ventilation, suction, and physiotherapy. Despite the advances in anesthesia and surgical techniques, the duration of mechanical ventilation (MV) may be prolonged after cardiac surgery, due to the classic high-dose narcotic-based cardiac anesthesia.
Trial arms
Trial start
2024-02-10
Estimated PCD
2026-02-01
Trial end
2026-02-10
Status
Recruiting
Treatment
Dexmedetomidine
to investigate the postoperative analgesic-sedative effect of dexmedetomidine versus fentanyl-midazolam to achieve fast-track extubation after adult valvular cardiac surgeries.
Arms:
Dexmedetomidine Group, Fentanyl Group
Other names:
fentanyl 50 mcg/ml
Size
60
Primary endpoint
Pain Relieve
2 hours post operative
Eligibility criteria
Inclusion Criteria: - This study will include patients undergoing elective adult valvular cardiac surgeries Exclusion Criteria: * Patient refusal. * Emergent valve cardiac surgeries. * Patients with known hypersensitivity to study drugs. * History of uncontrolled diabetes or hypertension. * Impaired kidney or liver functions. * Perioperative hemodynamic instability.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-06-18

1 organization

1 product

1 indication

Organization
Egymedicalpedia
Product
Dexmedetomidine
Indication
Valvular Cardiac Surgery