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NCT Number: NCT06768021

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

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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Key information

Conditions

Anesthesia Outcomes Anesthesia Complication Anesthesia Induction Anesthesia Recovery Period Anesthesia and Procedure Related Time Intervals Anesthesia, Intravenous Behavior Communication Crying Disease Attributes Facies Motor Activity Nonverbal Communication Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System

Oakland, California, 94602, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Anesthesia Experience Survey

    Time frame: 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).

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

    Time frame: 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.

  3. Amount of medications used during the sedation

    Time frame: During the sedation

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

  4. Length of sedation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alameda Health System

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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