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Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Virtual Parental Presence on Induction of Anesthesia Versus Premedication With Midazolam: A Non-Inferiority Study

NCT05834049•Stanford University

Summary

This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.

Eligibility

Age

4 - 8 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•children from ages 4 years to 8 years old undergoing outpatient surgery
•children identified as needing premedication
•ASA physical status I, II or III
•planned inhalational induction
•children presenting from home prior to surgery (not an inpatient)
•English speaking parents and child

Exclusion Criteria

•children with developmental delay
•children with psychological / emotional disorders
•children with altered mental status
•children in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team
•children with language barrier
•children who are not accompanied by someone able to consent (ie legal guardian)
•children who are inpatient prior to surgery
•children with expected difficult intubation/airway
•children presenting for emergency surgery
•family history or personal history of malignant hyperthermia / risk of MH
+5 more criteria

Key Dates

Start Date

July 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 30, 2027

Last Updated

February 15, 2024

Enrollment

322

ESTIMATED participants

Conditions

AnxietySurgery

Interventions

Virtual Parental Presence on Induction of Anesthesia

BEHAVIORAL

Midazolam

BEHAVIORAL

Contacts

Thomas J Caruso, MD, PhD

CONTACT

650-723-5728 tjcaruso@stanford.edu

Man Yee Suen, BSc, MMed

CONTACT

650-723-5728 msuen@stanfordchildrens.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Inclusion Criteria

Exclusion Criteria

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