Propofol vs Sevoflurane in Cyanotic Congenital Heart Disease

NCT ID: NCT04125550

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-01-01

Brief 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.

Conditions

Cyanotic Congenital Heart Disease; Pediatric HD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group P

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 relaxants. 10 mg/kg/h propofol infusion and 5 µg/kg/h fentanyl infusion will be administered.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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.

Group S

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 relaxants. 2% sevoflurane inhalation and 5 µg/kg/h fentanyl infusion will be administered for the maintenance of anesthesia.

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

sevoflurane inhalation (2-8%) will be administered for anesthesia induction. 2% sevoflurane inhalation will be administered for the maintenance of anesthesia.

Interventions

Propofol

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.

Intervention Type: DRUG

Sevoflurane

sevoflurane inhalation (2-8%) will be administered for anesthesia induction. 2% sevoflurane inhalation will be administered for the maintenance of anesthesia.

Intervention Type: DRUG

Other Intervention Names

Sevorane

Eligibility Criteria

Inclusion Criteria

• 1-10 years old
• Patients with cyanotic congenital heart disease undergoing open heart surgery with CPB

Exclusion Criteria

• Patients with liver or renal dysfunction
• Patients with inflammatory disease
• Patients with hemostatic disorders
• Preoperative use of anti-inflammatory and/or antioxidant drugs

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Feride Karacaer

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feri̇de Karacaer

Role: STUDY_DIRECTOR

Cukurova University

Locations

Cukurova University

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Cyanotic children

Identifier Type: -

Identifier Source: org_study_id