Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04826627 |
| Other study ID # |
19-041 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2021 |
| Est. completion date |
April 15, 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University Hospital, Caen |
| Contact |
Jean-Philippe Salaün, MD |
| Phone |
+644295087 |
| Email |
salaunjeanphilippe[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
In 2018, the main societies of anesthesia (European Society Anaesthesiology, European Society
Pediatric Anesthesia, and Association des Anesthésistes Réanimateurs Pédiatriques
d'Expression Française) changed the current recommendations for preoperative fasting time in
children, reducing the time to last intake of clear liquids from two to one hour before
anesthetic induction. Prolonged fasting may have a deleterious impact on blood glucose
homeostasis. The consequences of intraoperative hypoglycemia in children can be serious in
the short term, but also in the long term. The objective of multicenter prospective,
observational cohort study is to investigate- in children younger than 24 months of age
undergoing scheduled conventional inpatient surgery- a correlation between the duration of
preoperative fasting, glycemic intraoperative homeostasis and the criteria of enhanced
recovery after surgery, which are the hospital length of stay (main outcome), postoperative
pain and postoperative nausea-vomiting (secondary outcomes). By identifying non-adherence to
fasting rules as one of the causes of prolonged hospitalization, this study will highlight
the need to develop effective strategies to promote adherence to fasting rules in pediatric
surgery and minimize the potential deleterious impact on intraoperative glycemic control.
Description:
Preoperative fasting instructions (6 hours for solids and formula, 4 hours for breast milk,
and 1 hour for clear liquids) will be explained to parents orally during the preoperative
anesthesia consultation and a written document, reminding them of these instructions, will be
given to them afterwards.
Upon arrival in the operating room, the anesthesiologist will record on a standardized
collection sheet the time of fasting as well as the premedication received (time of
paracetamol and/or ibuprofen, β2-mimetic aerosols, preoperative antibiotic therapy).
After anesthetic induction, once airway management and securing of the peripheral venous line
have been completed and before surgical setup, a capillary blood sample will be taken from
the earlobe or fingertip to measure blood glucose and ketone levels using a blood glucose and
ketone meter (FREESTYLE OPTIUM NEO H, ketone and blood sugar meter, calibration performed
prior to the study by the pharmacology department). A ketonemia will be considered abnormally
high if the ketone level is higher than 0.6 mmol/L (0.11g/L). Hypoglycemia will be defined as
a capillary blood glucose level less than <3.5 mmol/L (0.63 g/L)9. In case of hypoglycemia or
high ketonemia, a second capillary sample should be taken, taking care to change the sampling
area (ear or finger) and then an average of the two results should be taken. Capillary blood
glucose and ketone measurements are part of routine care in pediatric anesthesia. Therefore,
there will be no additional cost.
Intraoperative monitoring for all children will include a 3-lead ECG, pneumocardiograph,
non-invasive blood pressure measurement, pulse oximetry (SpO2), esophageal or rectal
temperature measurement, and capnography. A forced-air heating blanket will be used to warm
the patient during the procedure. Mean arterial pressure (MAP) will be documented after
induction of anesthesia, and hypotension will be defined as MAP < 45 mmHg7. Intraoperatively,
data will be collected from the patient's blood pressure.
Intraoperatively, the following data will be recorded on the standardized collection sheet:
anesthetic agents used (hypnotics and morphinics), intraoperative analgesics, anti-nausea
agents (dexamethasone, ondansetron), infusion fluids used (nature of the fluid, rate of
infusion), catecholamine (ephedrine), drugs that may interfere with blood sugar regulation.
In the recovery room, postoperative pain will be evaluated using the EVENDOL scale and by the
consumption of analgesics (total dose of paracetamol, ibuprofen, nalbuphine). The treatment
of postoperative nausea and vomiting, left to the discretion of the anaesthetist, will also
be recorded (total dose of ondansetron, droperidol, others).
After return to the department, the duration of hospitalization will be recorded. It will be
defined as the number of days between arrival in the operating room and departure from the
hospital. A clinically significant difference in length of stay will be considered a
difference of at least 4 hours of hospital stay.
