Clinical trial NCT06768021: Does Style of Pre-sedation Instructions Improve Patient Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery?
Official title: Does a Pre-sedation Guided Visualization Exercise Improve Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery: a Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia Outcomes
Anesthesia Complication
Anesthesia and Procedure Related Time Intervals
Anesthesia Recovery Period
Anesthesia, Intravenous
Anesthesia Induction
Keywords: Anesthesia Experience Survey
Ambulatory anesthesia
Intravenous sedation
Guided Visualization
Pre-sedation instructions
Anesthesia outcomes
Oral &amp; Maxillofacial Surgery (OMFS)
Face, Legs, Activity, Cry, Consolability (FLACC)
Lead sponsor: Alameda Health System
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2025-01-10
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Member(s) of the research team will reference the subject list and determine whether this subject is in the control or experimental group. Based on this grouping, the research team member will enter the operatory and give the corresponding style of standardized pre-sedation instructions to the subject.

The control group will receive standardized pre-sedation instructions. The intervention group will receive the same set of standardized pre-sedation instructions and a one-minute guided visualization. Once complete, the research team member(s) will leave the operatory and hand back off to the clinical team.

The clinical team will then administer the anesthetic and perform the surgery, recording amounts of medication delivered and FLACC scores at three points during the case (during local anesthesia, during the surgery, and 15-minutes after surgery).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: Anesthesia Experience Survey
timeFrame: Within 2 hours of the completion of surgery
measure: Face-Legs-Activity-Cry-Consolability (FLACC)
timeFrame: During local anesthesia, during surgery, and fifteen minutes after surgery has concluded
measure: Amount of medications used during the sedation
timeFrame: During the sedation
measure: Length of sedation
timeFrame: During the sedation
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System
state: California
Study officials:
References: