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NCT Number: NCT06624592

Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium

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.

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Key information

Conditions

Delirium on Emergence Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Lindsay Warner

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sevoflurane

Drug

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

Isoflurane

Drug

Subjects will receive standard of care anesthesia Isoflurane

Primary outcomes

  1. Number of subjects with emergence delirium

    Time frame: 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 outcomes

  1. Post Anesthesia Care Unit (PACU) length of stay

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

    Number of hours spent in PACU during recovery

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay Warner, MD

CONTACT

[email protected]

507-284-2511

Molly Herr, MD

CONTACT

[email protected]

507-284-2511

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Sevoflurane/Dexmedetomidine vs. Isoflurane and Their Effects on Pediatric Emergence Delirium

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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