Anesthesia OutcomesNCT06768021
Does Style of Pre-sedation Instructions Improve Patient Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery?
A study testing Guided visualization and standardized pre-sedation instructions and Standardized pre-sedation instructions only in people with Anesthesia Outcomes and Anesthesia Complication, run by Alameda Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 70 years
- Conditions the study is for
- Anesthesia Outcomes, Anesthesia Complication, Anesthesia and Procedure Related Time Intervals
- What is being tested?
- Guided visualization and standardized pre-sedation instructions and Standardized pre-sedation instructions only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 1 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System
Oakland, California, 94602
About this study
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
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
- Conditions
- Anesthesia Outcomes, Anesthesia Complication, Anesthesia and Procedure Related Time Intervals, Anesthesia Recovery Period, Anesthesia, Intravenous, Anesthesia Induction
- Being tested
- Guided visualization and standardized pre-sedation instructions, Standardized pre-sedation instructions only
- 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)
- Medical subject headings
- Facies, Motor Activity, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided visualization and standardized pre-sedation instructionsBehavioural
One arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.
Standardized pre-sedation instructions onlyBehavioural
One arm will receive standardized pre-sedation instructions only.
| Study group | Role | What they receive |
|---|---|---|
| Standardized pre-sedation instructions only group | Placebo comparator | This group will receive the standardized pre-sedation instructions only, with no guided visualization. Receives: Behavioral: Standardized pre-sedation instructions only |
| Guided visualization and standardized pre-sedation instructions group | Experimental | This arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization. Receives: Behavioral: Guided visualization and standardized pre-sedation instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Experience Survey
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).
Measured: Within 2 hours of the completion of surgery
Face-Legs-Activity-Cry-Consolability (FLACC)
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.
Measured: During local anesthesia, during surgery, and fifteen minutes after surgery has concluded
Amount of medications used during the sedation
The amount of each medication utilized during the sedation will be documented.
Measured: During the sedation
Length of 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.
Measured: During the sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 Jan 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alameda Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Omid Akramian, Alameda Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768021
- Sponsor's protocol ID
- IRB24-10151A
- Other IDs
- 24-42546
- Status last verified
- Apr 2026
- First submitted
- 31 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No