Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05737641 |
| Other study ID # |
CES 48_2022 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
July 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Centro Hospitalar de Entre o Douro e Vouga |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to determine whether the fasting duration required for patients
after consuming oral jelly is comparable to that after consuming water, prior to elective
surgery.
International guidelines for perioperative fasting recommend abstaining from clear fluids for
2 hours to minimize the risk of regurgitation and aspiration pneumonia. However, there are no
specific recommendations regarding the perioperative management of jelly consumption.
Current understanding emphasizes the benefits of minimizing preoperative fasting time,
including preventing dehydration and metabolic complications like ketoacidosis, as well as
potentially enhancing patient satisfaction.
Oral jelly consumption may offer advantages by improving preoperative hydration and providing
some nutritional support prior to procedures.
This crossover study will involve 25 adult volunteers. In the first phase, participants will
be randomly assigned to either oral intake of water or jelly, followed by the opposite
intervention in the second phase. Gastric content and volume will be assessed using gastric
ultrasound.
Description:
Prolonged preoperative fasting is associated with unfavorable outcomes, inducing a catabolic
state that may lead to metabolic disturbances such as ketoacidosis, insulin resistance,
dehydration, and increased postoperative complications such as surgical site infection and
delayed bowel function. To minimize fasting time, current guidelines from the American
Society of Anesthesiology advise clear fluid intake (water, tea, coffee, pulp-free fruit
juices, carbohydrate-rich beverages) up to 2 hours prior to elective procedures involving
general anesthesia, regional anesthesia, or procedural sedation and analgesia. Solids fasting
should extend to 6 to 8 hours, depending on the type of foods.
Jelly is a solid food, mostly composed of water. Among its other components, proteins,
responsible for its solidification, and sugars stand out. Thus, it may be a form of oral
hydration, associated with some nutritional value, but the appropriate preoperative fasting
time is not explicitly stated in the guidelines.
An important cause of mortality and morbidity associated with tracheal intubation is the
aspiration of gastric contents. It is important to ensure that restricting preoperative
fasting time does not compromise patient safety, thereby increasing this risk. While
carbohydrate-rich beverages are not associated with delays in gastric emptying, the same
cannot be said for protein-containing liquids.
Gastric ultrasound is a non-invasive, bedside-available, and reliable method for quantitative
and qualitative assessment of stomach contents. Although the minimum volume of gastric
contents associated with increased risk of aspiration is not known, some studies demonstrate
that volumes up to 1.5 mL/kg of clear fluids, in the absence of solid contents, are normal,
commonly seen in fasting adults, and are not associated with an increased risk of pulmonary
aspiration.
The aim of our study is to demonstrate that jelly ingestion, compared to water, is not
associated with larger cross-sectional area of the gastric antrum, behaving similarly to
clear fluids.
