| NCT ID | NCT06144177 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of South Carolina |
| Condition | Anesthesia Induction |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 240 participants in total. It began in 2024-04-16 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
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
Contact & Investigator
Natalie Barnett, M.D.
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06144177 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 6 Years, studying Anesthesia Induction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06144177 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06144177 currently recruiting?
Yes, NCT06144177 is actively recruiting participants. Contact the research team at nitchie@musc.edu for enrollment information.
Where is the NCT06144177 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06144177 clinical trial?
NCT06144177 is sponsored by Medical University of South Carolina. The principal investigator is Natalie Barnett, M.D. at Medical University of South Carolina. The trial plans to enroll 240 participants.