Status:
RECRUITING
Induction in the Dark
Lead Sponsor:
Medical University of South Carolina
Conditions:
Anesthesia Induction
Eligibility:
All Genders
2-6 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 22 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06144177
Start Date
April 16 2024
End Date
June 22 2026
Last Update
July 8 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425