Induction in the Dark

NCT06144177 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Pro00132312
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.

1. 1.darkened room and star projector with parental presence;
2. 2.preoperative midazolam 0.5 mg/kg by mouth and parental presence; or
3. 3.parental presence alone.

Conditions

Anesthesia Induction

Outcome Measures

Primary Outcomes (1)

• Mask acceptance

  Mask acceptance during inhalational mask induction as measured by the mask acceptance scale (MAS). The MAS is scored on a scale from 1-4 by evaluating if the child is calm and accepting of the mask (4), slightly scared but easily calmed (3), has moderate fear of the mask and is not easily calmed (2), or cries, screams, or is terrified (1) during induction when using the inhalation mask. A higher score is better.

  during induction evaluated up until the start of the scheduled surgery

Secondary Outcomes (5)

• Perioperative anxiety

  Measured preoperatively, then measured again during the entry to operating room.

• Parental satisfaction of induction experience

  evaluated after child's induction is complete up until the end of surgery

• Post-Operative Emergency Delirium

  from PACU arrival until discharge

• Behavioral Changes

  Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively

• Time to PACU discharge

  time in recovery, up to 30 days post-op

Study Arms (3)

Darkened room and star projector with parental presence

ACTIVE COMPARATOR

Subjects assigned to this arm, when in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on. They will also have a parent in the room with them during induction of anesthesia.

Other: Dark with star projector; Other: Parental Presence

Preoperative midazolam 0.5 mg/kg po and parental presence

ACTIVE COMPARATOR

Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.

Drug: Preoperative midazolam; Other: Parental Presence

Parental presence alone

ACTIVE COMPARATOR

Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.

Other: Parental Presence

Interventions

Dark with star projector OTHER

When in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on.

Darkened room and star projector with parental presence

Preoperative midazolam DRUG

Midazolam by mouth preoperatively.

Preoperative midazolam 0.5 mg/kg po and parental presence

Parental Presence OTHER

A parent or guardian will accompany the child into the OR and be present for the start of induction.

Darkened room and star projector with parental presence; Parental presence alone; Preoperative midazolam 0.5 mg/kg po and parental presence

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2 to 6 years old
• American Society of Anesthesiologists physical status I-II
• Outpatient elective surgical procedures
• Undergoing general anesthesia
• Parent or guardian willing to be present during induction

You may not qualify if:

• History of previous surgery
• Fear of the dark
• Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.
• Severe developmental delay
• Severe obvious, preoperative anxiety
• Patients currently using psychiatric medications
• Non-English speaking

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Study Officials

• Natalie Barnett, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Nitchie, MHA

CONTACT

843-792-1869; nitchie@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: April 16, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 22, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)