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Recruiting NCT06144177

Induction in the Dark

Phase IV Interventional Anesthesia Induction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dark with star projector, Preoperative midazolam, Parental Presence.
Who it may be relevant to
Registry conditions: Anesthesia Induction. Basic parameters: 2 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety

Overview

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

Interventions

  • Other Dark with star projector
    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.
  • Drug Preoperative midazolam
    Midazolam by mouth preoperatively.
  • Other Parental Presence
    A parent or guardian will accompany the child into the OR and be present for the start of induction.

Primary outcome measures

  • Mask acceptance [Time frame: during induction evaluated up until the start of the scheduled surgery]
Secondary outcome measures (5)
  • Perioperative anxiety [Time frame: Measured preoperatively, then measured again during the entry to operating room.]
  • Parental satisfaction of induction experience [Time frame: evaluated after child's induction is complete up until the end of surgery]
  • Post-Operative Emergency Delirium [Time frame: from PACU arrival until discharge]
  • Behavioral Changes [Time frame: Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively]
  • Time to PACU discharge [Time frame: time in recovery, up to 30 days post-op]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT06144177 · Pro00132312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗