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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06265610
Other study ID # 2022/186
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date October 1, 2023

Study information

Verified date February 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 18 Years
Eligibility 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 ? patients 2. Patients with Diabetes Mellitus 3. Patients with severe lung disease 4. Patients with psychiatric disorders 5. Patients with opioid addiction -

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Sibel Seçkin Pehlivan Kayseri Talas

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary intraoperative period During cardiology angiography procedures, patients' heart rate,measurements will be evaluated. an average of 2 hours
Primary postoperative period During cardiology angiography procedures, patients' eye opening time will be evaluated. an average of 2 hours
Primary hemodynamic parameters During cardiology angiography procedures, patienheart ts' mean arterial pressure (MAP),measurements will be evaluated. an average of 2 hours
Secondary Modified Aldrete Recovery Score Modified Aldrete Recovery Score will be evaluated in the postoperative period during the processing period
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