NCT03406481

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

January 15, 2018

Last Update Submit

August 24, 2022

Conditions

Fasting PeriodIntravascular Volume

Outcome Measures

Primary Outcomes (1)

  • the relationship between fasting period duration and fluid responsiveness

    March 2018

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients undergoing surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

February 1, 2018

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)