EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING: A RETROSPECTIVE COHORT STUDY

NCT05946928 | Completed

• 1 other identifier: 0032517/22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to assess the anxiolytic and sedative effect of OZALIN® / OZASED® (ADV6209) 0,25mg/Kg in children undergoing magnetic resonance imaging (MRI) under inhalational anesthesia. Our hypothesis is that compared to children who do not receive any premedication, palatability of OZALIN® / OZASED® by allowing an easier acceptance of the drug, improves the quality of anesthesia induction and postoperative behavioral outcome improving sedation and reducing the need for inhalation anesthetic which has been recognized as the main cause of post-procedural behavioral changes, including emergence agitation.

Conditions

Autism Spectrum Disorder; Premedication; Brain Neoplasms; Brain Pathology; Growth Retardation

Outcome Measures

Primary Outcomes (1)

• evaluation of patients' reactive behavior to facemask positioning for inhalational anesthesia induction.

  evaluation of patients' reactive behavior to facemask positioning for inhalational anesthesia induction evaluated on a four-point scale (Mask Acceptance Scale, MAS) indicating that child is cooperative and accept the mask readily (MAS=1), he is slight fearful and accepts the mask with mild resistance (MAS=2), with moderate struggle (MAS=3) or he resists strongly and must be restrained (MAS=4)

  30 minutes within premedication administration

Secondary Outcomes (7)

• the percentage of sevoflurane at which the child's eyes closed upon induction of general anesthesia

  procedure (at induction of general anesthesia)

• time to eye closure at induction of anesthesia;

  procedure (at induction of general anesthesia)

• patient degree of acceptance of the administered premedication

  30 minutes before induction of general anesthesia

• evaluation of OZALIN® / OZASED® anxiolytic efficacy

  30 minutes after premedication administration

• child's behavior on separation from the parent

  baseline (before induction of general anesthesia)

Study Arms (2)

Ozased group

50 patients premedicated with OZALIN® / OZASED®

Control group

50 patients who did not receive any premedication

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

the IRCCS Agostino Gemelli Foundation of Catholic University of Rome

You may qualify if:

• \- We included in the study 100 children (either gender), aged 1-10 years, American Society of Anaesthesiologists (ASA) physical status 1 and 3 who, between March and December 2022, received inhalation anesthesia for brain and spinal cord MRI for diagnostic investigations or postoperative and oncological follow-up

You may not qualify if:

• \) a history of hypersensitivity to midazolam; 2) chronic therapy with benzodiazepines; 3) acute respiratory tract infections; 4) psychiatric and behavioural disorders; 5) ASA physical status \>3.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, 00135, Italy

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Brain Neoplasms

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rossella Garra

  Fondazione Policlinico A. gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: March 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Non completely planned yet
• Access Criteria: Not completely planned yet

Locations

IT (1)