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RecruitingNCT06624592Updated Dec 16, 2025

Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

A Phase 3 interventional study of Sevoflurane and Isoflurane in Delirium on Emergence, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
2 Years to 7 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Delirium on Emergence

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03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's planned enrollment of 400 is above the median of 120 across 475 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    Isoflurane group

    Drug: Isoflurane

  • Active comparator
    Sevoflurane group

    Drug: Sevoflurane

Interventions

  • DrugSevoflurane

    Subjects will receive standard of care anesthesia Sevoflurane, with intravenous push Dexmedetomidine

  • DrugIsoflurane

    Subjects will receive standard of care anesthesia Isoflurane

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: Post-procedural (0-4 hours after anesthesiology drop off)

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    • Lindsay Warner · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06624592
Lead sponsor
Mayo Clinic
Responsible party
Lindsay L. Warner (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 3, 2024
Start date
Dec 20, 2024
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Dec 16, 2025

Study contacts

Lindsay Warner, MD
Contact
warner.lindsay@mayo.edu
507-284-2511
Molly Herr, MD
Contact
herr.molly@mayo.edu
507-284-2511
Lindsay Warner, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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