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

NCT04826627 | Unknown

• 1 other identifier: 19-041
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anesthesia Morbidity; Child, Only; Fasting Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• length of stay in hospital

  length of stay in hospital after surgery

  1 week

Interventions

glycemia OTHER

capillary glycemia

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (2)

CHU Caen Normandie

Caen, 14000, France

RECRUITING

Hôpital Necker Enfants Malades

Paris, 75015, France

NOT YET RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Interventions

Blood Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Jean-Philippe Salaün, MD

CONTACT

+644295087; salaunjeanphilippe@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 1, 2021
• Study Start: July 15, 2021
• Primary Completion: April 14, 2023
• Study Completion: April 15, 2023
• Last Updated: February 13, 2023

Record last verified: 2022-05

Locations

FR (2)