BridgeMD
New treatment option for Anesthesia Induction
Official title Induction in the Dark
ClinicalTrials.gov ID: NCT06144177
What this study is testing
What is Preoperative midazolam?
Preoperative midazolam is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anesthesia induction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 6
You may be able to join 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 likely can't join 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...
- Severe developmental delay
- Severe obvious, preoperative anxiety
- Patients currently using psychiatric medications
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.