A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia

A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia On Patient Outcomes In Pediatric Patients Undergoing Endovascular Intervention

A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study.

Study Overview

• Status: Completed
• Conditions: Cardiology; Pediatric Patients
• Intervention / Treatment: Procedure: TIVA/TCI

Detailed Description

A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study. Patients underwent standard electrocardiography (ECG) monitoring with heart rate (HR), noninvasive blood pressure (NIKB), peripheral oxygen saturation (SpO2) and Bispectral index (BIS). Baseline NIKB, SpO2 and HR were recorded before the procedure, intraoperatively and in the postoperative recovery unit. In the postoperative recovery unit, the patient's recovery time was also evaluated and recorded with the Modified Aldrete Recovery Score.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Talas
    • Kayseri, Talas, Turkey, 38039
      • Sibel Seckin Pehlivan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

children ages 3 to 18 with heart disease

Description

Inclusion Criteria:

1. Children weighing over 10 kg and between the ages of 3-18 who will undergo angiography
2. Patients who are not allergic to the drugs used

Exclusion Criteria:

1. ASA Ⅳ patients
2. Patients with Diabetes Mellitus
3. Patients with severe lung disease
4. Patients with psychiatric disorders
5. Patients with opioid addiction -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; Total intravenous anesthesia with target-controlled infusion (TCI/TIVA) was applied as an anesthesia method to be applied to patients during cardiology angiography procedures.	Procedure: TIVA/TCI; : The aim of this study was to evaluate the effects of total intravenous anesthesia with target-controlled infusion (TCI/TIVA) on intraoperative hemodynamic parameters and postoperative awakening criteria in pediatric endovascular intervention patients; Other Names: Inhalatıon
Group 2; In the anesthesia method to be applied to patients during cardiology angiography procedures, inhalation anesthesia was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative period	During cardiology angiography procedures, patients' heart rate,measurements will be evaluated.	an average of 2 hours
postoperative period	During cardiology angiography procedures, patients' eye opening time will be evaluated.	an average of 2 hours
hemodynamic parameters	During cardiology angiography procedures, patienheart ts' mean arterial pressure (MAP),measurements will be evaluated.	an average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Aldrete Recovery Score	Modified Aldrete Recovery Score will be evaluated in the postoperative period	during the processing period

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Director: Sibel Pehlivan, MD, TC Erciyes University; Principal Investigator: Mustafa Cakıllı, Department of Anaesthesiology and Reanimation, Yozgat City Hospital,; Principal Investigator: Ozlem OZ GERGIN, MD, Department of Anaesthesiology and Reanimation, Medical Faculty, Erciyes University; Principal Investigator: Ali BAYKAN, Prof, Department of Pedıatrıc Cardiology, Medical Faculty, Erciyes University; Principal Investigator: Recep AKSU, Prof, Department of Anaesthesiology and Reanimation, Medical Faculty, Erciyes University; Principal Investigator: Karamehmet YILDIZ, prof, Department of Anaesthesiology and Reanimation, Medical Faculty, Erciyes University

Publications and helpful links

General Publications

• Lerman J, Johr M. Inhalational anesthesia vs total intravenous anesthesia (TIVA) for pediatric anesthesia. Paediatr Anaesth. 2009 May;19(5):521-34. doi: 10.1111/j.1460-9592.2009.02962.x. No abstract available.
• Lerman J. TIVA, TCI, and pediatrics: where are we and where are we going? Paediatr Anaesth. 2010 Mar;20(3):273-8. doi: 10.1111/j.1460-9592.2009.03238.x. Epub 2010 Jan 19.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Propofol; Sevoflurane,; Target Controlled Infusion,
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2022/186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared upon reasonable request to the corresponding author.
• IPD Sharing Time Frame: Data can be shared upon reasonable request to the corresponding author.
• IPD Sharing Access Criteria: Data can be shared upon reasonable request to the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No