Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04875845 |
| Other study ID # |
GVES |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
April 30, 2019 |
Study information
| Verified date |
May 2021 |
| Source |
Indonesia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Preoperative fasting was a common practice to decrease perioperative aspiration risk.
Duration of fasting was proportional to gastric volume. Short fasting duration may increase
aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration
and hypoglycemia.
The objective of this study was to analyze gastric volume after 6-hour and 8-hour duration of
fasting after consumption of solid meal on patients scheduled for elective surgery.
This was a cohort study recruiting 37 subjects from January to February 2019. Subjects were
patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital,
Jakarta, Indonesia. Before fasting, all subjects consumed standard Cipto Mangunkusumo meal
and was later assessed for gastric volume using ultrasound at 6 and 8 hour after meal was
consumed.
Description:
Background. Preoperative fasting was a common practice to decrease perioperative aspiration
risk. Duration of fasting was proportional to gastric volume. Short fasting duration may
increase aspiration risk. However, prolonged perioperative fasting duration may lead to
dehydration and hypoglycemia. The protocols of 8 hours preoperative fasting was recommended
by American Society of Anesthesiologist (ASA) after a full meal. The meal recognized by ASA
to make this guidelines were Western diet that contains more fat. South East Asian (SEA)
standard solid meal mainly contains rice and less protein and fats. We hypothesized 6-hours
compared with 8-hours fasting was sufficient to provide ideal gastric volume for preoperative
fasting after SEA standard solid meal. The objective of this study was to analyze gastric
volume after 6-hour and 8-hour of fasting after consumption of SEA standard solid meal on
patients scheduled for elective surgery.
Methods This was a cohort study recruiting 37 subjects from January to February 2019.
Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo
Hospital, Jakarta, Indonesia. Inclusion criteria were age between 18 to 60 years old, have no
nutritional status disorder, and ASA physical status of 1 or 2. The exclusion criteria were
patients with diabetes mellitus, pregnancy, abdominal distention, history of dyspepsia, and
intestinal motility disturbances.
Subjects agreed to take part in the research, will be initial examined for obtaining
demographic data: age, weight and height, type of surgery to be performed, and preoperative
examinations. The subject will start 8 hours of fasting before the surgical planning time.
Before fasting, the subjects were given Cipto Mangunkusumo Hospital food standardized
nutritional levels. Subjects were given 1 hour to consume the food. Six hours after the
standard meal is consumed, an ultrasound examination will be performed in the right lateral
decubitus position to obtain ultrasound imaging of the antrum. After that, the subject
continued fasting until 8 hours after meal and ultrasound examination was performed using the
same technique to obtain images of ultrasound imaging of the antrum. Imaging pictures are
taken at the time relaxation of the antrum, between two contractions. The results of this
imaging are stored and assessments of antrum craniocaudal (CC) and anteroposterior (AP)
diameters were performed by research assistants who don't know when the image was taken.
These measurements were used to calculate Cross Sectional Area (CSA) using the formula of
CSA=(π×CC×AP)/4. The Gastric Volume (GV) was then calculated with the formula
GV=27.0+(14.6×CSA)-(1.28×age).
The primary data obtained was the result of repeated examinations. The analysis was adjusted
using the Bonferonni correction factor. Categorical data was analyzed using the McNemar test.
The results of data processing are displayed in tabular form. The gastric volume was grouped
into sufficient and insufficient with a border value of 1.5ml/kg.
