Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

NCT ID: NCT06624592

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Delirium on Emergence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Isoflurane group

Group Type ACTIVE_COMPARATOR

Isoflurane

Intervention Type DRUG

Subjects will receive standard of care anesthesia Isoflurane

Sevoflurane group

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

Interventions

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Sevoflurane

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

Intervention Type DRUG

Isoflurane

Subjects will receive standard of care anesthesia Isoflurane

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Lindsay L. Warner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lindsay Warner, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lindsay Warner, MD

Role: CONTACT

507-284-2511

Molly Herr, MD

Role: CONTACT

507-284-2511

Other Identifiers

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24-002252

Identifier Type: -

Identifier Source: org_study_id