Induction in the Dark

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 4

Conditions: Anesthesia Induction

Treatments: Drug: Preoperative midazolam; Other: Dark with star projector; Other: Parental Presence

Study type: Interventional

Funder types: Other

Identifiers

NCT06144177

Pro00132312

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Darkened room and star projector with parental presence

Active Comparator group

Description:

Subjects assigned to this arm, 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. They will also have a parent in the room with them during induction of anesthesia.

Treatment:

Other: Parental Presence

Other: Dark with star projector

Preoperative midazolam 0.5 mg/kg po and parental presence

Active Comparator group

Description:

Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.

Treatment:

Other: Parental Presence

Drug: Preoperative midazolam

Parental presence alone

Active Comparator group

Description:

Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.

Treatment:

Other: Parental Presence