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Induction in the Dark

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jun 15, 2026 to Apr 15, 2027 Completion date: Jun 22, 2026 to May 22, 2027v8 Show 1 more changeShow less
    • Completion date: Jun 22, 2026 to May 22, 2027
  2. Notable Primary completion date: Jun 15, 2025 to Jun 15, 2026 Completion date: Jun 22, 2025 to Jun 22, 2026v7 Show 1 more changeShow less
    • Completion date: Jun 22, 2025 to Jun 22, 2026
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 26, 2024 to Apr 16, 2024 · Site details revisedv5 Show 2 more changesShow less
    • Start date changed from estimate of Apr 26, 2024 to Apr 16, 2024
    • Site details revised
  5. Notable Start date: Feb 26, 2024 to Apr 26, 2024v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Dec 15, 2023 to Feb 26, 2024v3
  2. Minor Secondary endpoints revised (5)v2 See this version in full on ClinicalTrials.gov ↗
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06144177
Lead Sponsor Medical University of South Carolina
Conditions Anesthesia Induction
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov