Ketone body levels and capillary blood glucose levels response using three different clear liquids 1 hour before procedure in outpatient surgery patients from 1 to 47 months old.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000557730

Enrollment

152

Registered

2022-04-11

Start date

2022-05-02

Completion date

2022-10-31

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Fasting long periods in the paediatric population have been associated with fast progression to a metabolic state characterised by catabolism. Thenew preoperative fasting recommendations shorten the fasting time to 1 hour for clear liquids in pediatric patients undergoing ambulatory surgery. However, the options vary from water to sports drinks. Based on the different nutritional properties of each beverage, this research project aims to evaluate three different clear liquids at doses of 3 ml per kg offered 1 hour before anesthetic induction and their effect on metabolic level by measuring the value of ketone bodies and capillary blood glucose. Thus, it will be possible to have a more objective assessment when determining the clear liquid to be recommended.

Interventions

After the child is admitted to the admissions room, his/her personal data will be verified, 3 cc/kg of the beverage of the assigned group will be given at random (Gatorade®, aguapanela or water) one hour before the anesthetic induction and the parents or guardians will be informed that the child must consume the liquid in less than 5 minutes, once only. To monitor adherence to the intervention, the parents or guardians must return of empty beverage container, and and parents should supervise the intake of the liquid. Additionally, the exact time of ingestion of the drink will be noted. Before going to the operating room and anesthetic induction, the time elapsed since the time of drinking the clear liquid will be verified.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

1 Months to 47 Months

Healthy volunteers

Inclusion criteria

- Patients from 1 to 47 months old are scheduled for ambulatory surgery. - Patients whose parents or guardians sign the informed consent form. - American Society of Anesthesiologists ASA Classification I-II

Exclusion criteria

- Patients with a suspected or diagnosed history of gastrointestinal disorders (including gastroesophageal reflux, hiatal hernia or gastritis), renal failure, severe cerebral palsy, enteropathies, esophageal stricture, achalasia or diabetes mellitus. - Patients with a history of endocrine disorders. - Patients with chronic steroid use. - Time from time of consumption of clear liquid and anesthetic induction less than 1 hour or more than 2 hours.

Outcome results