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Recruiting NCT06624592

Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

Phase III Interventional Delirium on Emergence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sevoflurane, Isoflurane.
Who it may be relevant to
Registry conditions: Delirium on Emergence. Basic parameters: 2 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Number of subjects with emergence delirium [Time frame: Within 1 hour after dropped off by anesthesiology team]
Secondary outcome measures (1)
  • Post Anesthesia Care Unit (PACU) length of stay [Time frame: Post-procedural (0-4 hours after anesthesiology drop off)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06624592 · 24-002252

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗