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Anesthesia MorbidityGLYNEMCaenNCT04826627

Impact of Preoperative Fasting on Intraoperative Glycemic Homeostasis and Enhanced Recovery in Children

An observational study of Anesthesia Morbidity and Child, Only, run by University Hospital, Caen at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 0 to 24 months
What is being tested?
glycemia
How many people
300 participants
Where
2 sitesFrance
Study dates
15 Jul 2021to 15 Apr 2023
How long will I take part?
1 Week
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: * All children less than 24 months of age * scheduled for conventional inpatient surgery will be included

Who may be able to join

  • All children less than 24 months of age
  • scheduled for conventional inpatient surgery will be included

Who cannot join

  • Children receiving intravenous fluids during the fasting period
  • children managed in ambulatory surgery
  • children with an ASA score strictly greater than 3
  • children managed in the emergency operating room
  • children with an acute metabolic disorder
  • an endocrine pathology or a pathology requiring the chronic use of drugs modifying glycemia (insulin, oral antidiabetics, glucagon, gabapentin, antidepressants and neuroleptics, conversion enzyme inhibitors (CEI)
  • beta blockers, statins, anti-transplant treatments, corticoids, antimalarial drugs, the following antibiotics fluoroquinolones, doxycycline, sulfamethoxazole, trimethoprim)

Trial locations and contacts

2 sites in 1 country.

Jean-Philippe Salaün, MD contact

+644295087

salaunjeanphilippe@gmail.com

France2 sites, 2 recruiting
  • CHU Caen Normandie

    Caen, 14000

    Jean-Philippe Salaün, MD, +644295087, salaunjeanphilippe@gmail.com

    Recruiting
  • Hôpital Necker Enfants Malades

    Paris, 75015

    Gilles Orliaguet, MD,PhD, +144494458, gilles.orliaguet@aphp.fr

    Not yet recruiting

Other trials in France

About this study

Official title: Association Between Preoperative Fasting, Intraoperative Glycemic Control, and Hospital Lenght of Stay in Children Younger Than 24 Months of Age Undergoing Scheduled Conventional Inpatient Surgery

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.

Read the detailed 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.

Being tested
glycemia
Medical subject headings
Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • glycemiaOther

    capillary glycemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. length of stay in hospital

    length of stay in hospital after surgery

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start15 Jul 2021
  3. Primary completion14 Apr 2023 (estimated)
  4. Study completion15 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT04826627
Sponsor's protocol ID
19-041
Acronym
GLYNEMCaen
Status last verified
May 2022
First submitted
31 Mar 2021
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia Morbidity and Child, Only, run by University Hospital, Caen at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jean-Philippe Salaün, MD (+644295087, salaunjeanphilippe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

length of stay in hospital (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.

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