Anesthesia Clinical Trial
Official title:
Cardioprotective Effect of Ketamine-dexmeditomidine Versus Fentanyl-midazolam in Open-heart Surgery in Pediatrics: A Randomized Controlled Double-blinded Study
Verified date | February 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
congenital hearts are very sensitive and irritable to deal with, especially during repair defects, the child's heart is exposed to impaired myocardial function during the entire procedure. Moreover, reperfusion of the heart during open-heart surgery when the myocardium is exposed to a global ischaemic cardioplegic arrest can induce myocardial injury. Myocardial reperfusion injury activates neutrophils, which trigger an inflammatory response resulting in the generation of reactive oxygen species (ROS), cytokine release, and complement activation, which further induce more cardiac injury. In addition to the inflammatory response generated as a result of tissue reperfusion injury, there is a significant systemic inflammatory response that is triggered by cardiopulmonary bypass (CPB) during open-heart surgery
Status | Completed |
Enrollment | 81 |
Est. completion date | September 25, 2022 |
Est. primary completion date | September 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 24 Months |
Eligibility | Inclusion Criteria: - the American Society of Anesthesiologists II and III - elective open Congenital cardiac surgery(VSD, AV canal, and partial anomaly) using cardiopulmonary bypass Exclusion Criteria: - less than 6 months or more than 24 months. - weight < 5 kg. - cyanotic heart disease - patients with heart failure, an implantable pacemaker, pulmonary hypertension, preoperative administration of inotropic agents, serum creatinine higher than1.5 mg/dL, chronic liver disease, patients receiving sulfonylurea, theophylline, or allopurinol |
Country | Name | City | State |
---|---|---|---|
Egypt | Amany Hassan Saleh | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | troponin level | mean troponin level post arotic declamping. | 6 hours | |
Secondary | heart rates | records of reading till the end of the surgery | every 15 minutes | |
Secondary | aortic cross clamping | duration of clamping | 2 hours | |
Secondary | inotropic support | number of patients | 6 hours | |
Secondary | blood pressure | records of reading till the end of the surgery | every 15 minutes | |
Secondary | need of nitroglycerin infusion | number of patients | 6 hours |
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