evaluating the effect of reducing preoperative clear fluid fasting time on hemodynamic statue of a child before and after operation and evaluating the risk of pulmonary aspiration in 2 to 6 years old children
Design
clinical trial has a control group with a parallel group without blinding
the research will be performed on 96 patients .excel will be used for randomization
Settings and conduct
96 patients enter the study after and are divided into case and control groups. Complete collection and examination is performed. Parents will be given a full explanation on how to keep children fasting. With the cooperation of surgeons and anesthesiologists, in Tabriz shohada hospital,the day before the operation, the parents will be explained that one hour before the operation, with the help of a nurse, 4ml / Kg of plain water will be given to the child. Patients will not receive intravenous fluids before surgery. When entering the operating room hemodynamic status, nausea and vomiting during induction or awakening of the patient and the appearance of any signs of aspiration will be recorded in the recovery phase and chest x-ray in case of signs of signs Will be obtained for pulmonary aspiration.
Participants/Inclusion and exclusion criteria
Including criteria
1.Children between 2-6 years old
2.Time of operation under 2 hours
3.Obtaining parents' satisfaction
Excluding criteria
1.age below 2 years and over 6 years
2.parental dissatisfaction
3.operations over 2 hours
4.operations of gastrointestinal tract
5.history of special medications
6.history of a previous surgery
7.history of congenital anomalies
8.patients who undergo emergent surgeries
Intervention groups
Patients will receive 4ml/kg clear fluids one hour before entering operation room.Routin fasting time will be used in control group.
Main outcome variables
Signs of pulmonary aspiration;hemodynamic statue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220611055132N1
Registration date:2023-11-29, 1402/09/08
Registration timing:prospective
Last update:2023-11-29, 1402/09/08
Update count:0
Registration date
2023-11-29, 1402/09/08
Registrant information
Name
Maryam Hejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 1075
Email address
hejazimaryam28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of reducing preoperative clear fluid fasting time on hemodynamic status and risk of aspiration in 2-6 years old children
Public title
The effect of reduced clear fluid fasting time on hemodynamic status and risk of pulmonary aspiration in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children between 2-6 years old
Time of operation under 2hours
Obtaining parents' consent
Exclusion criteria:
age below 2 years and over 6 years
parental dissatisfaction
operations over 2 hours
operations of gastrointestinal tract
history of special medications
history of a previous surgery
history of congenital anomalies
patients who undergo emergent surgeries
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Using a Computerized randomization with block diagram the studied patients will be divided into interventional group and control group to reduce bias.The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical science