An Observational Study of Emergence and Hypoactive Delirium After Anesthesia

NCT05582005 | Unknown DMC

• 1 other identifier: 2023-9181
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Early postoperative negative behaviour (ePONB), such as pain, emergence delirium (ED) and hypoactive delirium, is a relevant clinical problem during recovery from anesthesia. Specifically, many children often present with different forms of negative behavior namely ED, hypoactive delirium or pain. Such negative behavior differs in terms of evolution, treatment, prognosis and clinical implications. Furthermore, there is overlap between tools used to measurement postoperative pain and ED. As a result, the assessment of the different forms of negative behavior are often compromised by the presence of postoperative pain. Therefore, the application of scales used to measure negative behaviour in postanesthetic, non-surgical patients aged 3 years and under scheduled for elective MRI may clarify the presence of ED, hypoactive delirium and pain. An improved understating of postanesthetic negative behavior is important in order to help implement appropriate measures so as to better treat these patients.

Conditions

Emergence Delirium; Hypoactive Delirium; Pain

Outcome Measures

Primary Outcomes (1)

• Post-anesthesia negative behaviors (pain, emergence delirium and hypoactive delirium)

  Validation of NIPE as a tool to predict and assess post-anesthesia negative behaviors.

  1 hour

Interventions

noninvasive blood pressure, 3 lead ECG, peripheral oxygen saturation DEVICE

Children 3 year old and younger, scheduled for elective MRI, that are not intubated or require higher oxygen support and with no parents/guardians refusal will be placed on an electrocardiogram during post-anesthesia recovery. The NIPE monitor will be connected to the patients monitor in the PACU. Values will be recorded from the time of patient awaking until the patient meets the discharge criteria from PACU not before 1 hour.

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preschool Children

You may qualify if:

• Children ≤ 3 years old, scheduled for elective MRI.
• Patients whose parents are fluent in French or English.

You may not qualify if:

• Intubated patients or have higher oxygen requirements
• Parent/guardian refusal
• As this study will be conducted with only one NIPE monitor, and it will be devoted to the patient for about 1 hours, two consecutive patients cannot be enrolled in the study. In this case, the second patient will be considered eligible but excluded, and data will not be collected.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H3C4C9, Canada

Location

MeSH Terms

Conditions

Emergence Delirium; Pain

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Gianluca Bertolizio, MD,FRCPC

CONTACT

514586-2674; gianluca.bertolizo@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, Associate Professor, Anesthesiologist

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 17, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

CA (1)