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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03406481
Other study ID # 09.2017.669
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date April 28, 2021

Study information

Verified date August 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The minimum period of fasting recommended by the 'American Society of Anesthesiologists' for the preoperative period is 6 hours for solid foods and 2 hours for clear liquids. Knowing the effect of preoperative fasting time on intravascular volume status may lead us to determine the amount of fluid to be administered intraoperatively. Cardiac preload static indicators are often insufficient to predict the need for fluid and are often measured by invasive methods. Knowing the adequacy of the preload is important in anesthesia practice; there is no hemodynamic benefit of fluid replacement in non-responsive patients. In this study, the investigators aimed to determine the effect of preoperative fasting period on cardiac index change after anesthesia induction in pediatric patients aged 5-12 years. The primary implication of this study is to determine the fasting period of fluid evacuation by assessing patients' intravascular volume status.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date April 28, 2021
Est. primary completion date April 28, 2021
Accepts healthy volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria: pediatric patients, aged between 5 to 12, undergoing surgery - Exclusion Criteria: any comorbidity -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the relationship between fasting period duration and fluid responsiveness March 2018
See also
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Completed NCT01388998 - Fluid Management Study to Evaluate Changes in Intravascular Volume After Applying Various Pressure Levels on the Caval Vein N/A
Completed NCT03673475 - Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness