This study is not yet accepting patients

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

a study on Anesthesia

Summary

Eligibility
for people ages 8-70 (full criteria)
Location
at Oakland, California
Dates
study started
completion around

Description

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

Official Title

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

Keywords

Anesthesia Outcomes, Anesthesia Complication, Anesthesia and Procedure Related Time Intervals, Anesthesia Recovery Period, Anesthesia, Intravenous, Anesthesia Induction, Anesthesia Experience Survey, Ambulatory anesthesia, Intravenous sedation, Guided Visualization, Pre-sedation instructions, Oral & Maxillofacial Surgery (OMFS), Face, Legs, Activity, Cry, Consolability (FLACC), Guided visualization and standardized pre-sedation instructions, Standardized pre-sedation instructions only

Eligibility

You can join if…

Open to people ages 8-70

  • 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.

You CAN'T join if...

  • 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)

Location

  • Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System
    Oakland California 94602 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Alameda Health System
ID
NCT06768021
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated