Propofol vs Sevoflurane in Cyanotic Congenital Heart Disease

NCT04125550 | Completed Phase 4

• 1 other identifier: Cyanotic children
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cyanotic Congenital Heart Disease; Pediatric HD

Outcome Measures

Primary Outcomes (1)

• Interleukin-6 level at postoperative 24.hours

  Serum interleukin-6 (IL-6) level will be measured.

  Interleukin-6 level at postoperative 24.hours

Secondary Outcomes (2)

• Tumor necrosis factor alpha (TNF-alpha) level

  Serum TNF-alpha level at postoperative 24.hours

• Total anti-oxidant status (TAS) level

  Serum TAS level at postoperative 24. hours

Study Arms (2)

Group P

EXPERIMENTAL

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.

Drug: Propofol

Group S

ACTIVE COMPARATOR

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.

Drug: Sevoflurane

Interventions

Propofol 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 P

Sevoflurane DRUG

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

Also known as: Sevorane

Group S

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Feri̇de Karacaer

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: October 14, 2019
• Study Start: January 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: January 1, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

TU (1)