Anesthesia and Procedure Related Time Intervals, Anesthesia Complication, Anesthesia Induction, Anesthesia, Intravenous, Anesthesia Outcomes, Anesthesia Recovery Period
Conditions
Keywords
Anesthesia Experience Survey, Ambulatory anesthesia, Intravenous sedation, Guided Visualization, Pre-sedation instructions, Anesthesia outcomes, Oral & Maxillofacial Surgery (OMFS), Face, Legs, Activity, Cry, Consolability (FLACC)
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
Interventions
BEHAVIORALGuided visualization and standardized pre-sedation instructions
One arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.
BEHAVIORALStandardized pre-sedation instructions only
One arm will receive standardized pre-sedation instructions only.
Sponsors
Alameda Health System
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
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).
Eligibility
Sex/Gender
ALL
Age
8 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia Experience Survey | Within 2 hours of the completion of surgery | 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). |
| Face-Legs-Activity-Cry-Consolability (FLACC) | During local anesthesia, during surgery, and fifteen minutes after surgery has concluded | 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. |
| Amount of medications used during the sedation | During the sedation | The amount of each medication utilized during the sedation will be documented. |
| Length of sedation | During the 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. |
Countries
United States
Outcome results
None listed