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Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

Sevoflurane/Dexmedetomidine vs. Isoflurane and Their Effects on Pediatric Emergence Delirium

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06624592
Enrollment
400
Registered
2024-10-03
Start date
2024-12-20
Completion date
2026-11-01
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium on Emergence

Brief 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.

Interventions

DRUGSevoflurane

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

DRUGIsoflurane

Subjects will receive standard of care anesthesia Isoflurane

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
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

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects with emergence deliriumWithin 1 hour after dropped off by anesthesiology teamTotal 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.

Secondary

MeasureTime frameDescription
Post Anesthesia Care Unit (PACU) length of stayPost-procedural (0-4 hours after anesthesiology drop off)Number of hours spent in PACU during recovery

Countries

United States

Contacts

Primary ContactLindsay Warner, MD
warner.lindsay@mayo.edu507-284-2511
Backup ContactMolly Herr, MD
herr.molly@mayo.edu507-284-2511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026