Propofol vs Sevoflurane in Cyanotic Congenital Heart Disease
Condition: Cyanotic Congenital Heart Disease; Pediatric HD
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.
    

Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): 2-3 mg/kg propofol will be administered for anesthesia induction. 10 mg/ kg/h propofol infusion will be administered for the maintenance of anesthesia.; sevoflurane inhalation (2-8%) will be administered for anesthesia induction. 2% sevoflurane inhalation will be administered for the maintenance of anesthesia.
Other intervention name(s): Sevorane
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention