Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

NCT06624592 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 24-002252
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Within 1 hour after dropped off by anesthesiology team

Secondary Outcomes (1)

• Post Anesthesia Care Unit (PACU) length of stay

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

Study Arms (2)

Isoflurane group

ACTIVE COMPARATOR

Drug: Isoflurane

Sevoflurane group

ACTIVE COMPARATOR

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

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

Sevoflurane group

Isoflurane DRUG

Subjects will receive standard of care anesthesia Isoflurane

Isoflurane group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sevoflurane; Isoflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Lindsay Warner, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Warner, MD

CONTACT

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

Molly Herr, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: October 3, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)