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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05314569
Other study ID # N-11-2022
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 15, 2022
Est. completion date September 25, 2022

Study information

Verified date February 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Myocardial protection is an important issue. This is reflected in the clinical prognosis of patients undergoing cardiac surgery and this can be measured by the most popular Cardiac biomarkers ( cardiac troponin I (cTnI)). (2) A large number of anesthetic agents have been implicated in protecting the heart against ischemia and reperfusion injury. Ketamine has an anti-inflammatory effect and has been shown to reduce ROS generation by neutrophils and to decrease endotoxin stimulated IL6 production in human whole blood although it does not impair neutrophil function. (3) Dexmedetomidine is a highly selective, short-acting, central α2-adrenergic agonist with intense sympatholytic qualities. Dexmedetomidine has been increasingly used as a component of general anesthesia, including cardiac surgical applications due to its sedative/hypnotic and analgesic effects which are enhanced by its cardioprotective properties. (4) Riha et.al showed that ketamine - Dexmedetomidine combination had superior cardioprotective effects as measured by cardiac markers as compared to sevoflurane- sufentanil anesthesia after cardiac surgery. (5) Midazolam is known to have potential anti-inflammatory effects and antioxidant activity. They have been proven to provide protective effects for patients who underwent cardiac surgery. (6) Fentanyl is one opioid that has been closely linked to inflammatory mediators and myocardial protection. It reduces the CPB-induced inflammatory response and ischaemic reperfusion injury during cardiac surgery. These effects are related to improvement in intracellular Ca2+ mobilization and do not seem to be related to the adhesion of neutrophils in the coronary system. (7) To the best of our knowledge, this is the first study comparing the combined effect of Ketamine- Dexmedetomidine versus fentanyl- midazolam against ischemia and reperfusion injury in pediatric congenital heart surgery repair.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine- dexmedetomidine
ketamine - Dexmedetomidine combination had superior cardioprotective effects as measured by cardiac markers as compared to sevoflurane- sufentanil anesthesia after cardiac surgery
Fentanyl- midazolam
Midazolam is known to have potential anti-inflammatory effects and antioxidant activity. They have been proven to provide protective effects for patients who underwent cardiac surgery.Fentanyl is one opioid that has been closely linked to inflammatory mediators and myocardial protection. It reduces the CPB-induced inflammatory response and ischaemic reperfusion injury during cardiac surgery
Isoflurane
Anesthetic inhalational gas

Locations

Country Name City State
Egypt Amany Hassan Saleh Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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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