Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

Phase 3RecruitingNCT06624592

Mayo Clinic400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

400

Conditions

Delirium on Emergence

Interventions

SevofluraneDRUG

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

IsofluraneDRUG

Subjects will receive standard of care anesthesia Isoflurane

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 Years

Medical Language ↔ Plain English

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).

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Within 1 hour after dropped off by anesthesiology team

Secondary Outcomes

Post Anesthesia Care Unit (PACU) length of stay

Number of hours spent in PACU during recovery

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

Central Contacts

Lindsay Warner, MD

CONTACT

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

Molly Herr, MD

CONTACT

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

Data from ClinicalTrials.gov

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