Delirium on EmergencePhase 3NCT06624592
Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium
A Phase 3 study testing Sevoflurane and Isoflurane in people with Delirium on Emergence, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to measure the incidences of pediatric emergence delirium between the group receiving Isoflurane and the group receiving Sevoflurane plus intravenous push dexmedetomidine. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Delirium on Emergence
- What is being tested?
- Sevoflurane and Isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2024to 1 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 2-7 years.
- Surgeries include ENT cases (i.e., tonsillectomy/adenoidectomy), ophthalmology cases (i.e., strabismus), and urology cases.
- Can be outpatient or General Care inpatient procedures.
- All cases must include an IV and an endotracheal tube (ETT).
Who cannot join
- Severe developmental/cognitive delay (unable to make eye contact, nonverbal, or inability to interact with providers for PAED scale assessment requirements)
- TIVA cases.
- No PIV in place during the case, planned PICU admission postoperatively.
- Previous history of severe emergence delirium documented by a provider (via interventions or explicitly stated).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Lindsay Warner
About this study
Official title: Sevoflurane/Dexmedetomidine vs. Isoflurane and Their Effects on Pediatric Emergence Delirium
The purpose of this study is to measure the incidences of pediatric emergence delirium between the group receiving Isoflurane and the group receiving Sevoflurane plus intravenous push dexmedetomidine.
- Conditions
- Delirium on Emergence
- Being tested
- Sevoflurane, Isoflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Subjects will receive standard of care anesthesia Sevoflurane, with intravenous push Dexmedetomidine
IsofluraneDrug
Subjects will receive standard of care anesthesia Isoflurane
| Study group | Role | What they receive |
|---|---|---|
| Isoflurane group | Active comparator | Not described Receives: Drug: Isoflurane |
| Sevoflurane group | Active comparator | Not described Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with emergence delirium
Total number of subjects with a Pediatric Anesthesia Emergence Delirium (PAED) score of > 10. The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable total score is 20.
Measured: Within 1 hour after dropped off by anesthesiology team
Secondary outcomes (1)
Post Anesthesia Care Unit (PACU) length of stay
Number of hours spent in PACU during recovery
Measured: Post-procedural (0-4 hours after anesthesiology drop off)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start20 Dec 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay L. Warner, Mayo Clinic
- Investigators
- Lindsay Warner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624592
- Sponsor's protocol ID
- 24-002252
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane/Dexmedetomidine vs. Isoflurane and Their Effects on Pediatric Emergence Delirium
- ClinicalTrials.gov ID
- NCT06624592
- Acronym / sponsor ID
- 24-002252
- Conditions
- Delirium on Emergence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- 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.
The purpose of this study is to measure the incidences of pediatric emergence delirium between the group receiving Isoflurane and the group receiving Sevoflurane plus intravenous push dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoflurane group | Active comparator | Drug: Isoflurane |
| Sevoflurane group | Active comparator | Drug: Sevoflurane |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged 2-7 years.
- Surgeries include ENT cases (i.e., tonsillectomy/adenoidectomy), ophthalmology cases (i.e., strabismus), and urology cases.
- Can be outpatient or General Care inpatient procedures.
- All cases must include an IV and an endotracheal tube (ETT).
Key exclusion criteria (4 listed)
- Severe developmental/cognitive delay (unable to make eye contact, nonverbal, or inability to interact with providers for PAED scale assessment requirements)
- TIVA cases.
- No PIV in place during the case, planned PICU admission postoperatively.
- Previous history of severe emergence delirium documented by a provider (via interventions or explicitly stated).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneSubjects will receive standard of care anesthesia Sevoflurane, with intravenous push Dexmedetomidine | Drug | Sevoflurane group |
| IsofluraneSubjects will receive standard of care anesthesia Isoflurane | Drug | Isoflurane group |
Primary outcome
Number of subjects with emergence delirium
Time frame: Within 1 hour after dropped off by anesthesiology team
Total number of subjects with a Pediatric Anesthesia Emergence Delirium (PAED) score of > 10. The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable total score is 20.
1 secondary outcome
Post Anesthesia Care Unit (PACU) length of stay
Time frame: Post-procedural (0-4 hours after anesthesiology drop off)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Lindsay Warner, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevoflurane and Isoflurane in people with Delirium on Emergence, run by Mayo Clinic 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Warner, MD (507-284-2511, warner.lindsay@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with emergence delirium (time frame: Within 1 hour after dropped off by anesthesiology team). 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 16 Dec 2025.