Comparing Sevoflurane and Isoflurane for Pediatric Delirium
Sevoflurane/Dexmedetomidine vs. Isoflurane and Their Effects on Pediatric Emergence Delirium
This study is testing whether using Sevoflurane with dexmedetomidine or just Isoflurane helps young children aged 2-7 have less confusion after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 2 Years to 7 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06624592 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the incidence of emergence delirium in pediatric patients aged 2-7 years undergoing surgeries such as tonsillectomy, adenoidectomy, and strabismus repair. Participants will receive either Isoflurane or a combination of Sevoflurane and dexmedetomidine during their procedures. The study will assess the effectiveness of these anesthetic approaches in reducing the occurrence of delirium upon emergence from anesthesia. The research is being conducted at the Mayo Clinic in Rochester, Minnesota.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 2-7 years undergoing specific outpatient or inpatient surgical procedures requiring general anesthesia.
Not a fit: Patients with severe developmental or cognitive delays, or those with a history of severe emergence delirium, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthetic protocols that minimize the risk of emergence delirium in young children.
How similar studies have performed: Previous studies have shown varying success with different anesthetic techniques in reducing emergence delirium, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay Warner, MD — Mayo Clinic
- Study coordinator: Lindsay Warner, MD
- Email: warner.lindsay@mayo.edu
- Phone: 507-284-2511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.