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

NCT ID: NCT05592964

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-04

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preoperative Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

preoperative period carbohydrate anxiety ultrasonography pediatrics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Standard fasting group.

Fasting

Intervention Type DIETARY_SUPPLEMENT

Standard fasting

Group S

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

Water

Intervention Type DIETARY_SUPPLEMENT

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.

Carbohydrate fluid

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fasting

Standard fasting

Intervention Type DIETARY_SUPPLEMENT

Water

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

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate fluid

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cukurova University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zehra Hatipoglu, MD

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Adana, Saricam, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10/2022

Identifier Type: -

Identifier Source: org_study_id