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

NCT05592964 | Completed

• 1 other identifier: 10/2022
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preoperative Anxiety

Keywords

preoperative period; carbohydrate; anxiety; ultrasonography; pediatrics

Outcome Measures

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

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

Secondary Outcomes (4)

• Evaluation of the Gastric residual volume values

  after 10 minutes anesthesia induction

• Evaluation of the blood pressures

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

• Blood sugar

  at the 20th minute.

• Evaluation of heart rates

  Change from heart rates at 20 minutes.

Study Arms (3)

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

Fasting DIETARY_SUPPLEMENT

Standard fasting

Group A

Water DIETARY_SUPPLEMENT

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

Group S

Carbohydrate fluid DIETARY_SUPPLEMENT

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

Group K

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ages of 5 and 12
• ASA Score of 1-2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation

Adana, Saricam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Angptl4 protein, mouse; Water

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 25, 2022
• Study Start: March 4, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

TU (1)