Does Style of Pre-sedation Instructions Improve Patient Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery?

Alameda Health System

Status: Enrolling

Conditions: Anesthesia Induction; Anesthesia Recovery Period; Anesthesia, Intravenous; Anesthesia Complication; Anesthesia and Procedure Related Time Intervals; Anesthesia Outcomes

Treatments: Behavioral: Guided visualization and standardized pre-sedation instructions; Behavioral: Standardized pre-sedation instructions only

Study type: Interventional

Funder types: Other

Identifiers

NCT06768021

IRB24-10151A

24-42546 (Other Identifier)

Details and patient eligibility

About

This randomized controlled trial aims to evaluate the impact of a brief guided visualization exercise on anesthesia-related outcomes in oral and maxillofacial surgery in patients scheduled for ambulatory anesthesia in the oral and maxillofacial surgery clinic. Researchers will compare these patients, who will receive the guided visualization exercise in addition to standardized pre-operative instructions, to patients who will only receive the standardized pre-operative instructions. The following outcomes will be measured for both groups:

• A seven-point Anesthesia Experience Survey
• Face-Legs-Activity-Cry-Consolability (FLACC) scores at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded
• Amount of medications used during the sedation
• Length of sedation

Enrollment: 300 estimated patients

Sex: All

Ages: 8 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects within ages 8 to 70.
• Subjects planned for ambulatory intravenous sedation in the oral and maxillofacial surgery clinic.
• Ability to understand verbal English or understand instructions using a sign-language or voice interpreter of their native language.

Exclusion criteria

• Subjects who cannot understand the instructions, even with an interpreter (extremes of age, cognitive impairments, severe psychiatric disease that may affect participation)
• Subjects not undergoing intravenous sedation (oral sedation, nitrous oxide, local anesthesia)
• Subjects undergoing anesthesia in other environments (gastrointestinal suite, operating rooms, interventional radiology)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Standardized pre-sedation instructions only group

Placebo Comparator group

Description:

This group will receive the standardized pre-sedation instructions only, with no guided visualization.

Treatment:

Behavioral: Standardized pre-sedation instructions only

Guided visualization and standardized pre-sedation instructions group

Experimental group

Description:

This arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.

Treatment:

Behavioral: Guided visualization and standardized pre-sedation instructions