Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000557730
Ethics application status
Approved
Date submitted
25/02/2022
Date registered
11/04/2022
Date last updated
11/04/2022
Date data sharing statement initially provided
11/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 306527 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic response to fasting 325410 0
Outpatient surgery 325778 0
Condition category
Condition code
Metabolic and Endocrine 322805 322805 0 0
Normal metabolism and endocrine development and function
Surgery 323116 323116 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322958 0
Treatment: Other
Comparator / control treatment
After the child is admitted to the admissions room, his/her personal data will be verified and no beverage will be given to the randomly assigned control group.
Control group
Active

Outcomes
Primary outcome [1] 330587 0
Ketone body levels using a finger-prick blood samples and FreeStyle Precision blood ß-ketone test strips.
Timepoint [1] 330587 0
one hour after intervention
Secondary outcome [1] 406809 0
Capillary glucose level using a finger-prick and FreeStyle Precision blood glucose test strips
Timepoint [1] 406809 0
One hour after intervention

Eligibility
Key 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
Minimum age
1 Months
Maximum age
47 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will be kept hidden by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated by permuted blocks size 4 using the random permutation generator application from randomization.org. The randomization sequence will be generated by the epidemiologist who will not be in contact with the patients or with the nursing or anesthesiology staff who will care for them. Anesthesiologists will be masked to the intervention given to the child one hour prior to surgery.

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous variables will be evaluated for normal distribution using the Kolmogorov-Smirnov test and will be presented as averages and standard deviation in the case of a normal distribution or as medians and interquartile range in the case of a non-normal distribution. Categorical variables are presented as frequency distributions. Differences between groups of continuous variables will be evaluated with Student's t-test (if they have normal distribution) or the Mann-Whitney U test (if they do not have normal distribution). Differences for categorical variables will be evaluated by the chi-square test or Fisher's exact test. A P value <0.05 will be considered statistically significant.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
31/10/2022
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment outside Australia
Country [1] 24620 0
Colombia
State/province [1] 24620 0
Caldas

Funding & Sponsors
Funding source category [1] 311105 0
Self funded/Unfunded
Name [1] 311105 0
Fernando Arango
Country [1] 311105 0
Colombia
Primary sponsor type
Individual
Name
Fernando Arango
Address
Facultad de Ciencias para la Salud
Universidad de Manizales
Carrera 9 A # 19-03
Manizales, Caldas
Colombia
Country
Colombia
Secondary sponsor category [1] 312436 0
None
Name [1] 312436 0
Address [1] 312436 0
Country [1] 312436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310432 0
Comite de Bioetica - Facultad de Ciencias para la Salud - Universidad de Caldas
Ethics committee address [1] 310432 0
Carrera 25 # 48 - 57
Facultad de Ciencias para la Salud
Manizales, 170001
Ethics committee country [1] 310432 0
Colombia
Date submitted for ethics approval [1] 310432 0
12/09/2021
Approval date [1] 310432 0
27/10/2021
Ethics approval number [1] 310432 0
CBCS-050

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117646 0
Dr Andres Felipe Murillo
Address 117646 0
Facultad de Ciencias para la Salud
Universidad de Caldas
Carrera 25 # 48-57
Manizales, Caldas
Colombia
Country 117646 0
Colombia
Phone 117646 0
+573127303994
Fax 117646 0
Email 117646 0
andres.7520137671@ucaldas.edu.co
Contact person for public queries
Name 117647 0
Dr Fernando Arango
Address 117647 0
Facultad de Ciencias para la Salud
Universidad de Manizales
Carrera 9 A # 19-03
Manizales, Caldas
Colombia
Country 117647 0
Colombia
Phone 117647 0
+573136520781
Fax 117647 0
Email 117647 0
farango32743@umanizales.edu.co
Contact person for scientific queries
Name 117648 0
Dr Fernando Arango
Address 117648 0
Facultad de Ciencias para la Salud
Universidad de Manizales
Carrera 9 A # 19-03
Manizales, Caldas
Colombia
Country 117648 0
Colombia
Phone 117648 0
+573136520781
Fax 117648 0
Email 117648 0
farango32743@umanizales.edu.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Clinical, laboratory and demographic data
When will data be available (start and end dates)?
Immediately following publication, available for 5 years after publication.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
andres.7520137671@ucaldas.edu.co
farango32743@umanizales.edu.co


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.