Delirium on EmergenceNCT02509221
Effect of Duration of Exposure of Anesthesia With Sevoflurane on Emergence Delirium
An observational study of Delirium on Emergence, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Delirium on Emergence
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients between 1-6 years old receiving anesthesia for non-surgical reasons
Who may be able to join
- age between 1-6 years of age
- receiving general anesthesia for non-surgical procedure
Who cannot join
- history of emergence delirium
- severe CNS disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Delirium on Emergence
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Less than 30 minutes | Not described | |
| 30-60 minutes | Not described | |
| More than 60 minutes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence delirium
using the PAED scale
Measured: 30 mintes after anesthesia
Severity of emergence delirium
using the PAED scale
Measured: 30 minutes after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium on EmergenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Resti, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509221
- Sponsor's protocol ID
- 714457
- Status last verified
- Aug 2023
- First submitted
- 23 Jul 2015
- Last updated
- 28 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Duration of Exposure of Anesthesia With Sevoflurane on Emergence Delirium
- ClinicalTrials.gov ID
- NCT02509221
- Acronym / sponsor ID
- 714457
- Conditions
- Delirium on Emergence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Less than 30 minutes | – | – |
| 30-60 minutes | – | – |
| More than 60 minutes | – | – |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients between 1-6 years old receiving anesthesia for non-surgical reasons
Key inclusion criteria (2 listed)
- age between 1-6 years of age
- receiving general anesthesia for non-surgical procedure
Key exclusion criteria (2 listed)
- history of emergence delirium
- severe CNS disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of emergence delirium
Time frame: 30 mintes after anesthesia
using the PAED scale
Severity of emergence delirium
Time frame: 30 minutes after anesthesia
using the PAED scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium on Emergence, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence delirium (time frame: 30 mintes after anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.