Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric... | NCT06624592

Studies
Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

NCT06624592

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Dec 16, 2025Actual

Enrollment

400Estimated

Phase

Phase 3

Conditions

Delirium on Emergence

Interventions

Sevoflurane
Isoflurane

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2024Actual

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Aug 21, 2024

First Submission Date that Met QC Criteria

Oct 1, 2024

First Posted Date

Oct 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2025

Last Update Posted Date

Dec 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isoflurane group	Active Comparator		Drug: Isoflurane
Sevoflurane group	Active Comparator		Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	Subjects will receive standard of care anesthesia Sevoflurane, with intravenous push Dexmedetomidine	Sevoflurane group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lindsay Warner, MD	Contact	507-284-2511		warner.lindsay@mayo.edu
Molly Herr, MD	Contact	507-284-2511		herr.molly@mayo.edu

Overall Officials

Name	Affiliation	Role
Lindsay Warner, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester	Recruiting	Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D007530	Isoflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided