Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000069550
Ethics application status
Approved
Date submitted
4/05/2023
Date registered
29/01/2024
Date last updated
29/01/2024
Date data sharing statement initially provided
29/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain connectivity in children under 4 months of age undergoing general anesthesia
Scientific title
Characterization of the states of consciousness during general anesthesia in children under 4 months of age through electroencephalographic analysis of brain connectivity
Secondary ID [1] 309592 0
None
Universal Trial Number (UTN)
U1111-1292-1018
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depth of anesthesia in babies 329895 0
Functional brain connectivity in babies 329896 0
Neurodevelopmental disorders caused by general anesthesia in infants 329897 0
Condition category
Condition code
Anaesthesiology 326806 326806 0 0
Anaesthetics
Neurological 326809 326809 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Hours
Description of intervention(s) / exposure
Participants will receive auditory and visual stimuli of 10 seconds during four moments delivered by a rheatre nurse: before anesthetic induction, during anesthetic induction, during surgical incision, and upon awakening. During the four moments, the electroencegalographic signals will be recorded with 16-channel surface EEG located in a 10/20 system. Auditory stimuli of 20 db and light stimuli of 50 cd/m2 will be performed for each ear and for each eye, respectively.
Intervention code [1] 326017 0
Not applicable
Comparator / control treatment
not control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334655 0
Characterization of functional brain connectivity assessed with surface EEG during different states of consciousness; Awake, sedated, surgical anesthesia, and postoperative awakening in infants younger than 4 months of age undergoing surgical procedures under general anesthesia with sevofluorane.
Timepoint [1] 334655 0
Before induction of anesthesia, during induction of anesthesia, during surgical anesthesia, and upon awakening from anesthesia
Secondary outcome [1] 421549 0
Spectrogram of brain electrical activity in infants younger than 4 months before anesthetic induction, during anesthetic induction, during surgical anesthesia, and upon awakening from anesthesia through the processing of electroencephalographic signals with MAT LAB
Timepoint [1] 421549 0
Before anesthetic induction, during anesthetic induction, during surgical anesthesia, and upon awakening from anesthesia.

Eligibility
Key inclusion criteria
Babies less than 4 months old, ASA I-II, undergoing general anesthesia
Minimum age
0 Days
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with genetic syndromes, with perinatal hypoxia, neurological disorders, or hemodynamic or metabolic instability

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 25430 0
Colombia
State/province [1] 25430 0
Caldas

Funding & Sponsors
Funding source category [1] 313774 0
Self funded/Unfunded
Name [1] 313774 0
Unfunded
Country [1] 313774 0
Primary sponsor type
Individual
Name
Alexander Trujillo M
Address
Facultad de Ciencias para la Salud, Universidad de Caldas Carrera 25 # 48 - 57 Manizales, Colombia
Country
Colombia
Secondary sponsor category [1] 315606 0
None
Name [1] 315606 0
none
Address [1] 315606 0
none
Country [1] 315606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312944 0
Comité de Bioética de la Universidad de Caldas
Ethics committee address [1] 312944 0
Calle 65 No 26 - 10, Manizales Caldas, Colombia
Ethics committee country [1] 312944 0
Colombia
Date submitted for ethics approval [1] 312944 0
29/09/2023
Approval date [1] 312944 0
13/10/2023
Ethics approval number [1] 312944 0
CBCS-057

Summary
Brief summary
We hypothesize that it is possible to characterize the different states of consciousness during general anesthesia with sevoflurane in children less than 4 months after surgery through electroencephalographic analysis of functional brain connectivity.
A convenience sample will be taken between September 2023 and October 24 of children under 4 months of age undergoing surgical procedures under general anesthesia with Sevoflurane at the Red Cross Children's Hospital in Manizales who meet the inclusion criteria.

A Cadwell Easy III brand 16-channel EEG will be used, which will be located according to the 10/20 system. EEG records will be taken at 4 times: before induction, during anesthetic induction, during surgery, and upon awakening.
The data will be processed minimally, following the convention for pediatric data with EEGLAB from MATLAB and analyzed to characterize functional brain connectivity at each of the 4 moments
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126426 0
Dr Alexander Trujillo
Address 126426 0
Facultad de Ciencias para la Salud, Universidad de CaldasCarrera 25 # 48 - 57Manizales, Colombia
Country 126426 0
Colombia
Phone 126426 0
+57 3128329419
Fax 126426 0
Email 126426 0
alexander.trujillo@ucaldas.edu.co
Contact person for public queries
Name 126427 0
Dr Alexander Trujillo
Address 126427 0
Facultad de Ciencias para la Salud, Universidad de CaldasCarrera 25 # 48 - 57Manizales, Colombia
Country 126427 0
Colombia
Phone 126427 0
+57 3128329419
Fax 126427 0
Email 126427 0
alexander.trujillo@ucaldas.edu.co
Contact person for scientific queries
Name 126428 0
Dr Alexander Trujillo
Address 126428 0
Facultad de Ciencias para la Salud, Universidad de CaldasCarrera 25 # 48 - 57Manizales, Colombia
Country 126428 0
Colombia
Phone 126428 0
+57 3128329419
Fax 126428 0
Email 126428 0
alexander.trujillo@ucaldas.edu.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The ethics committee does not permit sharing of de-identified individual participant data


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.