- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04826627
Impact of Preoperative Fasting on Intraoperative Glycemic Homeostasis and Enhanced Recovery in Children (GLYNEMCaen)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- CHU Caen Normandie
-
Paris, France, 75015
- Not yet recruiting
- Hôpital Necker Enfants Malades
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- All children less than 24 months of age
- scheduled for conventional inpatient surgery will be included
Description
Inclusion Criteria:
- All children less than 24 months of age
- scheduled for conventional inpatient surgery will be included
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length of stay in hospital
Time Frame: 1 week
|
length of stay in hospital after surgery
|
1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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