Sevoflurane/Dexmedetomidine Vs. Isoflurane for Pediatric Emergence Delirium

Phase 3

Recruiting

• Conditions: Delirium on Emergence
• Interventions: Drug: Isoflurane; Drug: Sevoflurane

• Registration Number: NCT06624592
• Lead Sponsor: Mayo Clinic

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 available

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoflurane group	Isoflurane	-
Sevoflurane group	Sevoflurane	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with emergence delirium	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States