- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05592964
The Effect of Oral Fluid Administration 1 Hour Before Surgery on Preoperative Anxiety and Gastric Volume in Pediatrics
The Effect of Oral Fluid Administration 1 Hour Before Surgery on Preoperative Anxiety and Gastric Volume in Pediatric Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Saricam
-
Adana, Saricam, Turkey, 01330
- Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ages of 5 and 12
- ASA Score of 1-2
Exclusion Criteria:
- ASA 3-4
- functional or anatomical disease related to the gastrointestinal tract, those with severe liver, kidney, cardiac or neurological disease
- patients using proton pump inhibitor or histamine 2 receptor blocker.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
Standard fasting group.
|
Standard fasting
|
Group S
The patient group who were given oral 5 ml/kg (maximum 250 ml) of water 1 hour ago.
|
In Group S, water was given 1 hour before the operation.
|
Group K
The patient group who were given an oral 5 ml/kg (maximum 250 ml) carbohydrate rich clear liquid 1 hour ago.
|
In Group K, carbohydrate fluid was given 1 hour before the operation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the Preoperative anxiety scores
Time Frame: Change from Baseline modified yale preoperative anxiety scale 1 hour after fluid
|
Modified Yale Preoperative Anxiety Scale (Scores: minimum:23.3-maximum:100) All children were evaluated with mYPAS (basal) when they came to the preoperative preparation room. Group S and K were then given oral fluid; similarly, after 1 hour, patients in all groups were again evaluated with m-YPAS score. The mYPAS is performed in children aged 5 to12 years old, both in the preoperative unit and during anesthesia induction, and it is widely used to evaluate children's anxiety before surgery, at the present time |
Change from Baseline modified yale preoperative anxiety scale 1 hour after fluid
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the Gastric residual volume values
Time Frame: after 10 minutes anesthesia induction
|
Measurement of gastric sections under ultrasound guidance.
After intubation, gastric antral cross-sectional area was measured by ultrasound.
Gastric residual volume (GRV) values were calculated.
|
after 10 minutes anesthesia induction
|
Evaluation of the blood pressures
Time Frame: Change from SBP, DBP, and MAP at 20 minutes.
|
noninvasive blood pressure measurement Systolic blood pressure (SBp), diastolic blood pressure (DBP), mean arterial pressure (MAP) were recorded before induction and at 5-minute intervals for the first 20 minutes after induction.
|
Change from SBP, DBP, and MAP at 20 minutes.
|
Blood sugar
Time Frame: at the 20th minute.
|
Glucose measurement with glucometer
|
at the 20th minute.
|
Evaluation of heart rates
Time Frame: Change from heart rates at 20 minutes.
|
Heart rates were recorded before induction and at 5-minute intervals for the first 20 minutes after induction.
|
Change from heart rates at 20 minutes.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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