Recruiting
Phase 3

Sevoflurane vs. Isoflurane

Sponsor:

Mayo Clinic

Code:

NCT06624592

Conditions

Delirium on Emergence

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Not accepted

Interventions

Sevoflurane

Isoflurane

Study Details

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.

Conditions

Delirium on Emergence

Study ID

NCT06624592

Start date

Dec 20, 2024

Status verified date

Dec, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Isoflurane group

active comparator: Sevoflurane group

Interventions

Sevoflurane

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

Isoflurane

Subjects will receive standard of care anesthesia Isoflurane

Primary outcome measure

  • Number of subjects with emergence delirium [ Time Frame: Within 1 hour after dropped off by anesthesiology team ]

Central Contacts and Locations

Central contacts

Lindsay Warner, MD

507-284-2511warner.lindsay@mayo.edu

Molly Herr, MD

507-284-2511herr.molly@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Lindsay Warner

More Information

Sponsor

Mayo Clinic

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-12-16.