Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03787849
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2018-12-18
Brief Title:
Epigenetics in PostOperative Pediatric Emergence Delirium
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Investigation of the DNA Methylation Profile in Children Who Presented Emergence Delirium
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPOPED
Brief Summary:
Emergence delirium ED infers the occurrence of behavior and cognition changes during the early postoperative period Main signs and symptoms of ED are the disturbances of consciousness and awareness of the environment with disorientation and perceptual alterations including hypersensitivity to external stimuli and hyperactive motor behaviors The incidence may be higher than 80 Risk factors include pre-school age use of sevoflurane ophthalmologic and otorhinolaryngologic surgeries child anxiety parental or caregiver anxiety The recurrence of ED is controversial The only validated scale for diagnosis of ED is the PAED Pediatric Anesthesia Emergence Delirium Prevention is the best approach as well as the use of alpha-2 agonists propofol and total intravenous anesthesia There are still no clear markers for postoperative delirium especially ED Cognitive alterations may be related to epigenetic modifications Anesthesia-induced epigenetic changes may be the key to understanding perioperative complications and outcomes and is a field of future research in anesthesia The study aims to analyze the DNA methylation profile in children with ED A prospective randomized study will be carried out in up to 322 children undergoing general anesthesia inhalation group or intravenous group to perform endoscopic procedures at the Instituto da Criança Hospital das Clinicas Faculdade de Medicina Universidade de Sao Paulo Brazil Patients will have blood samples drawn and analysis of the DNA methylation profile through the array technique will be performed in 40 children 20 of each group who presented ED as well as in 08 control cases Also the occurrence of ED will be correlated with the degree of anxiety of the child parents and during anesthetic induction in addition to comparing the two anesthetic techniques with the occurrence of ED and late postoperative cognitive alterations
Detailed Description:
BACKGROUND The risks of neurotoxicity and late cognitive impairment supported the recent US Food and Drug Administration FDA recommendation on caution in the indication of anesthesia in children up to 3 years of age Among the cognitive alterations related to pediatric anesthesia emergence delirium ED is frequent in pre-school children There is no consensus on the risk factors and forms of ED prevention which occurs more frequently after inhalation anesthesia On the other hand anesthesia-induced epigenetic changes may be the key to understanding various complications and perioperative outcomes There are no specific biomarkers for ED Such biomarkers would be used to measure the risk of ED and would contribute to prevention and treatment It has been hypothesized that behavioral changes in ED may be related to epigenetic modifications analyzed through the DNA methylation profile OBJECTIVES The primary aim of the study is to investigate the DNA methylation profile in children with ED The secondary objectives are to evaluate the correlation between the DNA methylation profile with the anesthetic technique and the degree of preoperative anxiety METHODS Children N322 from 1 to 12 years old candidates to digestive endoscopy under general anesthesia will be recruited in an outpatient clinic from a tertiary university hospital After informed consent the child and parents preoperative anxiety will be assessed through the modified Yale Preoperative Anxiety Scale mYPAS and VAS-Anx Anxiety Visual Analogic Scale respectively The quality of anesthetic induction will be evaluated through Pediatric Anesthesia Behavior PAB scale and Perioperative Adult Child Behavior Interaction Scale PACBIS After inhaled induction with sevoflurane blood sample collection will be performed to evaluate DNA methylation followed by randomization in two groups to maintain anesthesia using the venous technique with propofol or inhaled anesthesia with sevoflurane Upon awakening the ED will be evaluated through PAED Pediatric Anesthesia Emergence Delirium scale Twenty children from each group presenting ED as well as 08 control cases will have their venous blood samples sent for DNA methylation analysis using the array technique After hospital discharge the postoperative behavioral changes will be observed through the PHBQ Post Hospitalization Behavior Questionnaire questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None