Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Surgery
• Interventions: Behavioral: Virtual Parental Presence on Induction of Anesthesia; Behavioral: Midazolam

• Registration Number: NCT05834049
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-04-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Study Start: 2025-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 322

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Parental Presence on Induction of Anesthesia group	Virtual Parental Presence on Induction of Anesthesia	Use of Facetime with child and parents during induction
Midazolam Group	Midazolam	0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.