Complication of Anesthesia Clinical Trial
Official title:
The Protective Effect of the α2-agonist Dexmedetomidine on Mitochondrial Structure and Function for Children With Non-cyanotic Congenital Heart Defects Having Cardiac Surgery: A Randomized Controlled Trial.
The investigators hypothesize that in addition to a known sympatholytic effect, intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and structure attenuating ischaemia-reperfusion and end-organ injury for children with non cyanotic congenital heart defects having corrective heart surgery.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 36 Months |
Eligibility |
Inclusion Criteria: - aged between 3 - 36 months - having primary corrective heart surgery Exclusion Criteria: - recent surgery (< 3 months) - previous chemotherapy - previous transfusion of blood products - neurodevelopmental disorders (including Trisomy 21) - supplemental oxygen requirement (< 3 months) - asthma requiring regular therapy - obstructive sleep apnea - the presence of concurrent infection or inflammation - a known allergy to dexmedetomidine hydrochloride |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Analgesic effects (Morphine equivalent dose of narcotics consumed) | Morphine equivalent dose of narcotics consumed | Perioperative (from induction of anesthesia for 24 hours) | |
Other | Sedative effects (Duration of intubation) | Duration of intubation. | Perioperative (from induction of anesthesia for 24 hours) | |
Primary | Mitochondrial function (use high content imaging (HCI) | The primary outcomes for mitochondria will be grouped into mitochondrial function, morphology, content and mtDNA damage. | Intraoperative | |
Secondary | Creatinine level (Marker of acute renal injury) | Marker of acute renal injury | Postoperative day 1 | |
Secondary | Cardiac function (Left ventricular ejection fraction measured by trans-thoracic echocardiography) | Left ventricular ejection fraction measured by trans-thoracic echocardiography | Postoperative day 1 | |
Secondary | Inotropes and vasopressors (Duration and dose of inotropes and vasopressors after surgery) | Duration and dose of inotropes and vasopressors after surgery | Postoperative day 1 |
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