Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05592964 |
| Other study ID # |
10/2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 4, 2022 |
| Est. completion date |
August 30, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
