NCT06265610

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

January 12, 2024

Last Update Submit

November 15, 2024

Conditions

Pediatric PatientsCardiology

Keywords

Sevoflurane,PropofolTarget Controlled Infusion,

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Modified Aldrete Recovery Score

    during the processing period

Study Arms (2)

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

Group 2

In the anesthesia method to be applied to patients during cardiology angiography procedures, inhalation anesthesia was applied.

Interventions

TIVA/TCIPROCEDURE

: 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

Also known as: Inhalatıon
group 1

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

children ages 3 to 18 with heart disease

You may qualify if:

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

You may not qualify if:

  • ASA Ⅳ patients
  • Patients with Diabetes Mellitus
  • Patients with severe lung disease
  • Patients with psychiatric disorders
  • Patients with opioid addiction -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibel Seçkin Pehlivan

Kayseri, Talas, 38039, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 19453585RESULT

  • 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.

    PMID: 20102520RESULT

Study Officials

  • Sibel Pehlivan, MD

    TC Erciyes University

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 20, 2024

Study Start

March 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Data can be shared upon reasonable request to the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data can be shared upon reasonable request to the corresponding author.
Access Criteria
Data can be shared upon reasonable request to the corresponding author.

Locations

TU(1)