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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Surgery
• Intervention / Treatment: Behavioral: Virtual Parental Presence on Induction of Anesthesia; Behavioral: Midazolam

• Study Type: Interventional
• Enrollment (Estimated): 322
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas J Caruso, MD, PhD; Phone Number: 650-723-5728; Email: tjcaruso@stanford.edu
• Study Contact Backup: Name: Man Yee Suen, BSc, MMed; Phone Number: 650-723-5728; Email: msuen@stanfordchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midazolam Group; 0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively.	Behavioral: Midazolam; Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated.
Experimental: Virtual Parental Presence on Induction of Anesthesia group; Use of Facetime with child and parents during induction	Behavioral: Virtual Parental Presence on Induction of Anesthesia; Apple Inc's FaceTime™ video application will be used when the child is taken to the operating room; Other Names: VPPIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction compliance	The Induction Compliance Checklist (ICC) is a validated observational scale, used to describe the compliance of a child during induction of anesthesia. ICC contains 10 items. Score ranges from 0 to 1. 0 point indicates the behavior is not observed while 1 point means behavior is observed.	immediately during anesthetic induction
Change of parental anxiety	The State-Trait Anxiety Inventory (STAI) is the gold standard for assessing anxiety in adults and has been used in over 1000 studies. It is comprises 20 questions. The total score ranges from 0-63. 0-9 indicates normal or no anxiety; 10-18 indicates mild to moderate anxiety; 19-29 indicates moderate to severe anxiety; and 30-63 indicates severe anxiety.	baseline, immediately after anesthetic induction

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Nationwide Children's Hospital
• Investigators: Principal Investigator: Vanessa Olbrecht, MD, MBA, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 69571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No