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

NCT06768021 — Not applicable, Completed, 128 participants, Alameda Health System

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Does a Pre-sedation Guided Visualization Exercise Improve Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery: A Double-blinded, Randomized Controlled Trial

RegistryNCT06768021
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, supportive care
Enrollment128 (Actual)
SponsorAlameda Health System (Other); collaborators: University of California, San Francisco
ConditionsAnesthesia Outcomes, Anesthesia Complication, Anesthesia and Procedure Related Time Intervals, Anesthesia Recovery Period, Anesthesia, Intravenous, Anesthesia Induction
InterventionsGuided visualization and standardized pre-sedation instructions, Standardized pre-sedation instructions only (Behavioral)
Datesstart 2025-01-02, primary completion 2026-04-01, completion 2026-04-01, first posted 2025-01-10, last updated 2026-04-30
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Anesthesia Outcomes All trials for Anesthesia Complication All trials of Guided visualization and standardized pre-sedation instructions All trials of Standardized pre-sedation instructions only

-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

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+Arms and interventions

ArmTypeInterventionsDescription
Standardized pre-sedation instructions only groupPlacebo comparatorBehavioral: Standardized pre-sedation instructions onlyThis group will receive the standardized pre-sedation instructions only, with no guided visualization.
Guided visualization and standardized pre-sedation instructions groupExperimentalBehavioral: Guided visualization and standardized pre-sedation instructionsThis arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.
  • Guided visualization and standardized pre-sedation instructions (Behavioral): One arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.
  • Standardized pre-sedation instructions only (Behavioral): One arm will receive standardized pre-sedation instructions only.

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 8 Years to 70 Years

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)

+Locations (1)

FacilityCityCountryStatus
Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health SystemOakland, CaliforniaUnited States