Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04125550 |
| Other study ID # |
Cyanotic children |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
January 1, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The stress response to surgery compromises a series of humoral, metabolic, or cellular
reactions. Cardiac surgery with use of cardiopulmonary bypass (CPB) is a major activator of
the systemic inflammatory response (SIRS). Inflammation, resulting in neutrophil activation,
plays a central role in the production of reactive oxygen species (ROS). Inflammatory and
oxidative reactions may play a role in the more frequent observation of postoperative
ventricular dysfunction in patients with cyanotic congenital heart disease (CHD) undergoing
surgery. The aim of this study is to compare the anti-inflammatory and anti-oxidant effects
of propofol and sevoflurane in children with cyanotic CHD undergoing open heart surgery with
CPB.
Description:
The stress response to surgery compromises a series of humoral, metabolic, or cellular
reactions. Cardiac surgery with use of cardiopulmonary bypass (CPB) is a major activator of
the systemic inflammatory response (SIRS). Inflammation, resulting in neutrophil activation,
plays a central role in the production of reactive oxygen species (ROS). Neutrophil
activation and IRI during CPB plays a central role the production of free radicals. An
imbalance between the free radicals and the antioxidant capacity of the body results
oxidative stress, which leads to lipid, protein and DNA damage Despite significant
refinements over the years, inflammation remain major concerns when using CPB.
SIRS was more prevalent in patients operated for tetralogy of Fallot and cyanotic syndromes.
It has been shown that pro-inflammatory cytokines are present in the myocardium of patients
with congenital heart disease and concentrations are higher in cyanotic patients than in
acyanotic patients. During CPB, more free oxygen radical production occurs in response to
reoxygenation after chronic cyanosis. Inflammatory and oxidative reactions may play a role in
the more frequent observation of postoperative ventricular dysfunction in patients with
cyanotic congenital heart disease (CHD) undergoing surgery.
Propofol has been suggested as a useful adjunct to CPB because of its potential protective
effect on the heart mediated by a decrease in ischemia-reperfusion injury and inflammation at
clinically relevant concentrations. The anti-inflammatory potential of sevoflurane has been
confirmed in several clinical studies, including patients undergoing cardiac surgery with the
use of CPB.
The goal of anesthetic management of children with CHD is to ensure an ongoing intraoperative
and postoperative cardiovascular stability with attenuation of the stress response and
nociceptive stimulation. Postoperative morbidity and mortality may be reduced by anesthetic
agents which prevent inflammatory and oxidative reactions. The aim of this study is to
compare the anti-inflammatory effects of propofol and sevoflurane in children with cyanotic
CHD undergoing open heart surgery with CPB.
34 patients aged 1-10 years undergoing open heart surgery for cyanotic congenital heart
disease will be included in the study.Patients will be randomly divided into two groups.
In Group S, sevoflurane inhalation (2-8%), 5 microgr/kg intravenous (iv) fentanyl will be
administered for anesthesia induction and 0.6 mg/kg rocuronium will be used as muscle
relaxant. 2% sevoflurane inhalation and 5 µg/kg/h fentanyl infusion will be administered for
the maintenance of anesthesia.
In Group P, 2-3 mg/kg propofol, 5 µg/kg iv fentanyl will be administered for anesthesia
induction and 0.6 mg/kg rocuronium will be used as muscle relaxant. 10 mg/ kg/h propofol
infusion and 5 µg/kg/h fentanyl infusion will be administered for the maintenance of
anesthesia..
Blood samples were collected at four time points: before operation (T0), after release of the
aortic cross-clamp (T1), at the end of the operation (T2), 24 h after the operation (T3). The
blood samples were centrifuged at 1,000xg for 15 min and the serum samples were stored at -80
0C until analysis.
Serum interleukin-6 (IL-6) tumor necrosis alpha (TNF-alpha), total anti-oxidant status (TAS)
and total oxidant status (TOS) levels will be measured.
In the postoperative period, age-specific SIRS criteria determined by the International
Pediatric Sepsis Consensus Conference will be used. Patients will be evaluated for SIRS
diagnosis at 6, 12 and 24 hours postoperatively.
