Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

NCT05834049 | Withdrawn

• 1 other identifier: 69571
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anxiety; Surgery

Outcome Measures

Primary Outcomes (1)

• Change of Anxiety in children

  We will be using the modified Yale Preoperative Anxiety Scale (mYPAS) which was developed specifically to measure anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults. It has a good validity against the State-Trait Anxiety Inventory for Children, as well as good intra and inter-observer reliability. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety.

  baseline, immediately after the intervention

Secondary Outcomes (2)

• Induction compliance

  immediately during anesthetic induction

• Change of parental anxiety

  baseline, immediately after anesthetic induction

Study Arms (2)

Virtual Parental Presence on Induction of Anesthesia group

EXPERIMENTAL

Use of Facetime with child and parents during induction

Behavioral: Virtual Parental Presence on Induction of Anesthesia

Midazolam Group

EXPERIMENTAL

0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively.

Behavioral: Midazolam

Interventions

Virtual Parental Presence on Induction of Anesthesia BEHAVIORAL

Apple Inc's FaceTime™ video application will be used when the child is taken to the operating room

Also known as: VPPIA

Virtual Parental Presence on Induction of Anesthesia group

Midazolam BEHAVIORAL

Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated.

Midazolam Group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• consent not obtained or withdrawal of consent
• children with past history of violent behaviors during induction of anesthesia
• cancellation of surgery
• patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19, including patients being treated with airborne precautions in the operating room
• receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) ketamine, and/or dexmedetomidine.

Sponsors & Collaborators

• Stanford University: lead
• Nationwide Children's Hospital: collaborator

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vanessa Olbrecht, MD, MBA

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 28, 2023
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share