Clinical trial NCT05592964: The Effect of Oral Fluid Administration 1 Hour Before Surgery on Preoperative Anxiety and Gastric Volume in Pediatrics
Official title: The Effect of Oral Fluid Administration 1 Hour Before Surgery on Preoperative Anxiety and Gastric Volume in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Anxiety
Keywords: preoperative period
carbohydrate
anxiety
ultrasonography
pediatrics
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It was carried out by the Pediatric Surgery and Eye Departments in children who underwent elective surgery.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the Preoperative anxiety scores
timeFrame: Change from Baseline modified yale preoperative anxiety scale 1 hour after fluid
Secondary outcomes:
measure: Evaluation of the Gastric residual volume values
timeFrame: after 10 minutes anesthesia induction
measure: Evaluation of the blood pressures
timeFrame: Change from SBP, DBP, and MAP at 20 minutes.
measure: Blood sugar
timeFrame: at the 20th minute.
measure: Evaluation of heart rates
timeFrame: Change from heart rates at 20 minutes.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation
state: Saricam
Study officials:
References: