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Preoperative AnxietyNCT05592964

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

An observational study of Preoperative Anxiety, run by Cukurova University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Preoperative Anxiety
What is being tested?
Fasting, Water and Carbohydrate fluid
Type of treatment
Pill or oral medicine
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Mar 2022to 30 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

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

    Adana, Saricam, 01330

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Oral Fluid Administration 1 Hour Before Surgery on Preoperative Anxiety and Gastric Volume in Pediatric Patients

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.

Being tested
Fasting, Water, Carbohydrate fluid
Keywords
preoperative period, carbohydrate, anxiety, ultrasonography, pediatrics
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FastingDietary supplement

    Standard fasting

  • WaterDietary supplement

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

  • Carbohydrate fluidDietary supplement

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

Study groups in NCT05592964
Study groupRoleWhat they receive
Group AStandard fasting group.
Receives: Dietary Supplement: Fasting
Group SThe patient group who were given oral 5 ml/kg (maximum 250 ml) of water 1 hour ago.
Receives: Dietary Supplement: Water
Group KThe patient group who were given an oral 5 ml/kg (maximum 250 ml) carbohydrate rich clear liquid 1 hour ago.
Receives: Dietary Supplement: Carbohydrate fluid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)
  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.

    Measured: 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.

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

  3. Blood sugar

    Glucose measurement with glucometer

    Measured: 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.

    Measured: Change from heart rates at 20 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2022
  2. Study start4 Mar 2022
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592964
Sponsor's protocol ID
10/2022
Status last verified
Oct 2022
First submitted
5 Oct 2022
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Preoperative Anxiety, run by Cukurova University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the Preoperative anxiety scores (time frame: Change from Baseline modified yale preoperative anxiety scale 1 hour after fluid). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.

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