Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05834049
• Other study ID #: 69571
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2025
• Est. completion date: December 30, 2027

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Thomas J Caruso, MD, PhD
• Phone: 650-723-5728
• Email: tjcaruso[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 322
• Est. completion date: December 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Nationwide Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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