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CompletedNCT05592964Updated Oct 31, 2022

The Effect of Oral Fluid Administration 1 Hour Before Surgery on Preoperative Anxiety and Gastric Volume in Pediatrics

An observational study in Preoperative Anxiety, sponsored by Cukurova University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-10-31.

Sponsored by Cukurova University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
5 Years to 12 Years
Sex
All
01

Study summary

It is a randomized, controlled and prospectively planned observational study.In our study, oral fluid administration 1 hour before surgery in children aged 5-12 years was aimed at preoperative anxiety level as the primary objective; The secondary objective is to evaluate the effects on gastric volume, hemodynamics and blood sugar.The study included 90 paediatric patients aged 5-12 years with ASA score 1-2. Group A (n=30): Standard fasting group. Group S (n=30): A group of patients who were given oral 5 ml/kg (maximum 250 ml) of water 1 hour ago. Group K (n=30): A group of patients who were given an oral 5 ml/kg (maximum 250 ml) carbohydrate rich clear liquid 1 hour ago. All patients were evaluated with the modified Yale Preoperative Anxiety Scale (m-YPAS) before and 1 hour after fluids were administered. After anesthesia, gastric antrum cross-sectional area (GACSA) was measured. Gastric residual volume (GRV) values were calculated. Hemodynamic data, blood sugar levels and parental satisfaction were recorded.

Read the detailed description

The study included 90 patients between the ages of 5 and 12 with an ASA Score of 1-2 who were scheduled for elective surgery (circumcision, strabismus, orchiopexy, hypospadias, splenectomy, vaginoplasty, laparoscopic gonadal research, epididymis cyst, inguinal hernia). ASA 3-4 was planned to exclude patients with a 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. Parents and children were informed about the study during the preoperative visit; written and verbal consents were obtained from those who accepted. Patients who participated in the study were randomly divided into three groups:Group A (n=30): Standard fasting group. Group S (n=30): A group of patients who were given oral 5 ml/kg (maximum 250 ml) of water 1 hour ago. Group K (n=30): A group of patients who were given an oral 5 ml/kg (maximum 250 ml) carbohydrate rich clear liquid 1 hour ago.Demographic data (gender, age, height, weight, body mass index (BMI), ASA score and co-morbidity) of the children taken to the preoperative waiting room were recorded. None of them underwent premedication. Patients in all groups were evaluated with m-YPAS score (basal). Patients in Group S and K were then given oral fluid; similarly, after 1 hour, patients in all groups were again evaluated with m-YPAS score.Standard monitoring (electrocardiography, peripheral oxygen saturation and noninvasive blood pressure) was applied to all patients who were taken to the operating room with their parents 1 hour after oral fluids were administered. After the induction of anesthesia was achieved with 2 mg/kg propofol (iv) and 0.6 mg/kg rocuronium (iv), intubation was performed with endotracheal tube appropriate for the age of the children. Anesthesia maintenance was achieved with 2% sevofluran and N2O/O2 40/60% inhalation anesthetics. Ringer Lactate 5-10 ml/kg was preferred for intravenous fluid maintenance.Patients were given the right lateral decubitus position after intubation. GACSA was identified by convex ultrasound (Esaote, myLabtm Six) probe in the abdominal setting, left lobe of the liver and superior mesenteric vein in the sagittal plane. GACSA was measured by determining the anterior-posterior (D1) and cranial-caudal (D2) distances (GAA: D1 x D2 x π / 4). The volume of gastric residue was calculated using a mathematical formula [GRV:-7.8 + (3.5xGAA) + 0.127xage (monthly)]. .In the study, there were two different people who evaluated the basal and m-YPAS scores 1 hour later and performed abdominal USG and were blind.Complications such as vomiting and aspiration that may occur during induction of anesthesia were recorded. Glucose measurement with glucometer (Freestyle Optimum Neo H) was performed at the 20th minute. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (OAB), heart rate (HR) were recorded before induction and at intervals of 5 minutes for the first 20 minutes after induction.At the end of surgery, a combination of 0.015 mg/kg atropine + 0.05 mg/kg neostigmine (iv) was applied to terminate the neuromuscular block. After it was decided that breathing and muscle activity were at an adequate level, tracheal extubation was performed and the patient was taken to the recovery room. Parental satisfaction (very good, good or dissatisfied) was assessed in the recovery room. According to the modified Aldrete compilation scoring, patients who scored 9 ≥ were sent to the their bed.

02

Conditions studied

  • Preoperative Anxiety

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Keywords

  • preoperative period
  • carbohydrate
  • anxiety
  • ultrasonography
  • pediatrics
03

In context

Anxiety Disorders

5,073 studies on the registry are indexed under Anxiety Disorders; 1,406 are open to participants now.

This study's enrollment of 90 is below the median of 148 across 630 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Cukurova University is the lead sponsor of 258 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

It was carried out by the Pediatric Surgery and Eye Departments in children who underwent elective surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ages of 5 and 12
  • ASA Score of 1-2

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A

    Standard fasting group.

    Dietary Supplement: Fasting

  • Group S

    The patient group who were given oral 5 ml/kg (maximum 250 ml) of water 1 hour ago.

    Dietary Supplement: Water

  • Group K

    The patient group who were given an oral 5 ml/kg (maximum 250 ml) carbohydrate rich clear liquid 1 hour ago.

    Dietary Supplement: Carbohydrate fluid

Interventions

  • Dietary supplementFasting

    Standard fasting

  • Dietary supplementWater

    In Group S, water was given 1 hour before the operation.

  • Dietary supplementCarbohydrate fluid

    In Group K, carbohydrate fluid was given 1 hour before the operation.

06

What researchers measure

Primary outcomes

  1. Evaluation of the Preoperative anxiety scores

    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

    Time frame: Change from Baseline modified yale preoperative anxiety scale 1 hour after fluid

Secondary outcomes

  1. Evaluation of the Gastric residual volume values

    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.

    Time frame: after 10 minutes anesthesia induction

  2. Evaluation of the blood pressures

    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.

    Time frame: Change from SBP, DBP, and MAP at 20 minutes.

  3. Blood sugar

    Glucose measurement with glucometer

    Time frame: at the 20th minute.

  4. Evaluation of heart rates

    Heart rates were recorded before induction and at 5-minute intervals for the first 20 minutes after induction.

    Time frame: Change from heart rates at 20 minutes.

07

Study locations

1 site
  • Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation
    Adana, Saricam 01330, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Aug 2022, 5 months.

Of 262 non-industry observational studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 52. This study's 5 months is below that.

Counting every sponsor, half of 284 studies reached it within 18 months; a quarter within 6 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2022
First posted
Oct 25, 2022
StartActual
Mar 4, 2022
Primary completionActual
Aug 30, 2022
CompletionActual
Aug 30, 2022
Last update
Oct 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05592964
Responsible party
Zehra Hatipoglu, MD (associate professor, Cukurova University) — Principal investigator
First posted
Oct 25, 2022
Start date
Mar 4, 2022
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022
Last update
Oct 31, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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