Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

Mayo Clinic

Status and phase: Enrolling; Phase 3

Conditions: Delirium on Emergence

Treatments: Drug: Sevoflurane; Drug: Isoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT06624592

24-002252

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Isoflurane group

Active Comparator group

Treatment:

Drug: Isoflurane

Sevoflurane group

Active Comparator group

Treatment:

Drug: Sevoflurane