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

Alameda Health System300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

300

Conditions

Anesthesia Outcomes Anesthesia Complication Anesthesia and Procedure Related Time Intervals

Interventions

Guided visualization and standardized pre-sedation instructionsBEHAVIORAL

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

Standardized pre-sedation instructions onlyBEHAVIORAL

One arm will receive standardized pre-sedation instructions only.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Anesthesia Experience Survey

A seven-point survey given after the patient meets Aldrete score discharge criteria, asking the following: how the patient rates their pre-operative anxiety level (0-10), if the patient has any recall of surgery (0 for none, 1 for a little, 2 for everything), if the patient remembers any pain during surgery (0 for none, 1 for a little, 2 for a lot), if the patient feels any nausea (0 for none, 1 for a little, 2 for a lot, 3 for vomiting), if the patient feels any pain now (0 for none, 1 for a little, 2 for a lot), if the patient feels any itching (0 for none, 1 for a little, 2 for a lot), and how satisfied the patient is overall with the sedation/anesthesia experience (0-10).

Time frame: Within 2 hours of the completion of surgery

Face-Legs-Activity-Cry-Consolability (FLACC)

Face-Legs-Activity-Cry-Consolability (FLACC) is a behavioral scale primarily designed for scoring postoperative pain in infants and young children, but can also be used to assess intraoperative and postoperative pain in adults undergoing intravenous sedation. The scale gives 0, 1, or 2 points for each of the following: the appearance of the patient's face, the appearance of the patient's legs, the amount of activity, the presence of crying, and the extent of consolability, for a total of 10 points. 0-3 points corresponds to mild pain, 4-6 to moderate pain, and 7-10 to severe pain. The scores will be taken at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded.

Time frame: During local anesthesia, during surgery, and fifteen minutes after surgery has concluded

Amount of medications used during the sedation

The amount of each medication utilized during the sedation will be documented.

Time frame: During the sedation

Length of sedation

The length of sedation will be measured, with the start point as the administration of the first sedative medication, and the endpoint as the end of phase I of anesthesia recovery, which will be determined with the Aldrete Scoring System.