Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05834049
• Collaborator: Nationwide Children's Hospital (Other)
• Enrollment: 322
• Arms: 2
• Anticipated Duration (Months): 42

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Surgery	Behavioral: Virtual Parental Presence on Induction of Anesthesia; Behavioral: Midazolam	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 322 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Virtual Parental Presence on Induction of Anesthesia Versus Premedication With Midazolam: A Non-Inferiority Study
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

1. Change of Anxiety in children [baseline, immediately after the intervention]

   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.

Secondary Outcome Measures

1. Induction compliance [immediately during anesthetic induction]

   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.

2. Change of parental anxiety [baseline, immediately after anesthetic induction]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Stanford University
• Nationwide Children's Hospital

Investigators

• Principal Investigator: Vanessa Olbrecht, MD, MBA, Nationwide Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Caruso, Clinical Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT05834049
• Other Study ID Numbers: 69571
• First Posted: Apr 28, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Midazolam

Study Results

No Results Posted as of May 1, 2023