Skip to content

The effect of Dexmedetomidine added to Del-Nido cardioplegic solution on the myocardial protection in pediatrics

The effect of Dexmedetomidine added to Del-Nido cardioplegic solution on the myocardial protection in pediatrics undergoing congenital heart defects surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240415061492N1
Enrollment
60
Registered
2024-05-10
Start date
2024-05-14
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital malformation of heart. Q24.9 - Congenital malformation of heart, unspecified

Interventions

Intervention 1: Intervention group: In this group, before administering the cardioplegia solution, dexmedetomidine drug (Pfizer, United States of America) at the rate of 50 µg/ml (in a 2 ml syringe l

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 6 Years

Inclusion criteria

Inclusion criteria: All pediatric patients aged between one month and 6 years Having parental consent to participate in the study Congenital heart defects with RACHS=1 and RACHS=2

Exclusion criteria

Exclusion criteria: Including the lack of written parental consent to enter the study Presence of coagulation disorders before surgery Liver dysfunction with increased SGOT, SGPT more than 1.5 times the baseline level before surgery Presence of congenital kidney diseases

Design outcomes

Primary

MeasureTime frame
Serum troponin-I level of patients , with Paying attention to checking the level of this index in the degree of myocardial protection was considered as the primary outcome. Timepoint: before entering the operating room (T0), after entering the ICU (T1), 12 hours after entering the ICU (T2), and 24 hours after entering the ICU (T3). Method of measurement: In order to check the troponin-I level of patients, a blood sample will be taken from the child along with other routine tests. For example, blood samples are taken from all patients before surgery to check biochemical tests and hemoglobin levels, and troponin-I tests are performed along with these tests without the need to take extra blood samples from the patient.;Coronary sinus lactate level of patients. Timepoint: Immediately after starting CPB and opening the right atrium and before cross-clamping (T0), immediately before removing the transverse aortic clamp (T1), and ten minutes after removing the transverse aortic clamp (T2). Method of measurement: After opening the right atrium and starting CPB, with the cooperation of the surgical team, a blood sample of 0.5 ml is taken from the patient's coronary sinus, which is checked for lactate level in less than a minute with the help of the 3000 gem premier device. Subsequent samples are taken from the coronary sinus at a specified time.;Serum CK-MB level of patients. Timepoint: before entering the operating room (T0), after entering the ICU (T1), 12 hours after entering the ICU (T2), and 24 hours after entering the ICU (T3). Method of measurement: In order to check the CK-MB level of patients, a blood sample will be taken from the child along with other routine tests. For example, blood samples are taken from all patients before the operation to check the biochemical tests and hemoglobin level, and the CK-MB test is performed along with these measurements without the need to take extra blood samples from the patient.

Secondary

MeasureTime frame
Serum glucose levels. Timepoint: before entering the operating room (T0), after entering the ICU (T1), and 24 hours after entering the ICU (T3). Method of measurement: Determining the glucose level of patients is done routinely and by the order of the surgeon at the specified times through CVL catheter sampling in all patients. .For the mentioned study, there is no need to take extra blood samples from the patient.;Blood urea nitrogen. Timepoint: before entering the operating room (T0), after entering the ICU (T1), and 24 hours after entering the ICU (T3). Method of measurement: Determining the BUN level of patients is done routinely and by the order of the surgeon at the specified times through CVL catheter sampling in all patients .For the mentioned study, there is no need to take extra blood samples from the patient.;Measuring the serum osmolarity level by checking the sodium level. Timepoint: before entering the operating room (T0), after entering the ICU (T1), and 24 hours after entering the ICU (T3). Method of measurement: Determining the Na level of patients is done routinely and by the order of the surgeon at the specified times through CVL catheter sampling in all patients .For the mentioned study, there is no need to take extra blood samples from the patient.;Investigating the occurrence of AKI through measurement of serum creatinine level. Timepoint: before entering the operating room (T0), after entering the ICU (T1), and 24 hours after entering the ICU (T3). Method of measurement: Determining the serum creatinine level of patients is done routinely and by the order of the surgeon at the specified times through CVL catheter sampling in all patients .For the mentioned study, there is no need to take extra blood samples from the patient. Acute kidney injury will be defined based on a more than 50% increase in serum creatinine level or an increase in serum creatinine by 0.3 mg/dL compared to the baseline.;(VIS) :Vasopressor-inotropic score(The amount of i

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarhad Samadieh

Mashhad University of Medical Sciences

samadiehf3@mums.ac.ir+98 51 3762 9945

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026