Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

December 14, 2025 updated by: Lindsay L. Warner, Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Lindsay Warner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isoflurane group
Drug: Isoflurane
Subjects will receive standard of care anesthesia Isoflurane
Active Comparator: Sevoflurane group
Drug: Sevoflurane
Subjects will receive standard of care anesthesia Sevoflurane, with intravenous push Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 1 hour after dropped off by anesthesiology team

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Anesthesia Care Unit (PACU) length of stay
Time Frame: Post-procedural (0-4 hours after anesthesiology drop off)
Number of hours spent in PACU during recovery
Post-procedural (0-4 hours after anesthesiology drop off)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Lindsay Warner, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-002252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Delirium on Emergence

Clinical Trials on Isoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe