- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509221
Effect of Duration of Exposure of Anesthesia With Sevoflurane on Emergence Delirium
August 24, 2023 updated by: Joseph Resti, State University of New York - Upstate Medical University
Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with Sevoflurane.
Restless recovery from anesthesia may not only cause injury to the child or to the surgical site, but may also lead to the accidental removal of surgical dressings, IV catheters, and drains.
is one of the The purpose of the study is to find whether duration of exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Syracuse, New York, United States, 13210
- University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pediatric patients between 1-6 years old receiving anesthesia for non-surgical reasons
Description
Inclusion Criteria:
- age between 1-6 years of age
- receiving general anesthesia for non-surgical procedure
Exclusion Criteria:
- history of emergence delirium
- severe CNS disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Less than 30 minutes
|
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30-60 minutes
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More than 60 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of emergence delirium
Time Frame: 30 mintes after anesthesia
|
using the PAED scale
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30 mintes after anesthesia
|
|
Severity of emergence delirium
Time Frame: 30 minutes after anesthesia
|
using the PAED scale
|
30 minutes after anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
July 23, 2015
First Submitted That Met QC Criteria
July 23, 2015
First Posted (Estimated)
July 27, 2015
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 714457
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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