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

Not Applicable

Recruiting

• Conditions: Anesthesia Recovery Period; Anesthesia Outcomes; Anesthesia Complication; Anesthesia and Procedure Related Time Intervals; Anesthesia, Intravenous; Anesthesia Induction

• Registration Number: NCT06768021
• Lead Sponsor: Alameda Health System

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-31
• Study Start: 2025-01-02
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System; 🇺🇸 Oakland, California, United States