Clinical trial

The Role of Ketamine and Dexmedetomidine in Opioid-Sparing Analgesia and Sedation in Adult Patients After Cardiac Surgery. A Randomized Clinical Trial

Name
H123
Description
Optimal multimodal opioid-sparing analgesic technique is considered as one of the most important Enhanced recovery pathways (ERPs) or enhanced recovery after surgery (ERAS) interventions that mitigate the undesirable effects of surgical stress response. Implementation of ERP has been shown to reduce postoperative complications and shorten the hospital LOS.
Trial arms
Trial start
2022-08-05
Estimated PCD
2023-05-10
Trial end
2023-05-20
Status
Completed
Treatment
Ketamine
drug
Arms:
Group (C), Group (D), Group (K)
Other names:
dexmedetomidine
Size
90
Primary endpoint
The total postoperative fentanyl consumption (μg)
the first 48 hours postoperative
Eligibility criteria
Inclusion Criteria: * Age 18 - 65 years * Ejection fraction (EF) \> 35% * Elective isolated CABG * Valve surgery, Atrial septal defect (ASD) closure * Cross clamp time ≤ 90 min * Cardiopulmonary bypass time ≤ 120 min. Exclusion Criteria: * Poor left ventricular function with intra-aortic balloon pump support * Recent myocardial infarction (last seven days) * Combined procedure (i.e., CABG + other heart/vascular procedure) * Emergency surgery, and Redo surgery,Hepatic or renal failure, creatinine \>1.5 -History of neurological disorders or convulsions
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2023-05-24

1 organization

1 drug

1 indication