Guided Visualization for Anesthesia

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Alameda Health System

Disqualifiers: Cognitive impairments, Severe psychiatric disease, others

Trial Summary

What is the purpose of this 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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is guided visualization for anesthesia safe for humans?

The research articles provided do not specifically address the safety of guided visualization for anesthesia, but they emphasize the importance of reporting and analyzing adverse events in anesthesia to improve patient safety. This suggests that safety is a key focus in anesthesia practices, though specific data on guided visualization is not available. ^{1 2 3 4 5}

How is guided visualization for anesthesia different from other treatments?

Guided visualization for anesthesia is unique because it uses mental imagery to help patients relax and manage pain, unlike traditional methods that rely on physical interventions like drugs or injections. This approach can be particularly beneficial for patients who prefer non-invasive techniques or want to reduce their reliance on medication. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

This trial is for patients scheduled for oral and maxillofacial surgery under ambulatory anesthesia. Participants must be eligible to receive intravenous anesthesia without any conditions that would complicate sedation or recovery.

Inclusion Criteria

Ability to understand verbal English or understand instructions using a sign-language or voice interpreter of their native language

I am scheduled for sedation during oral surgery.

I am between 8 and 70 years old.

Exclusion Criteria

Subjects who cannot understand the instructions, even with an interpreter (extremes of age, cognitive impairments, severe psychiatric disease that may affect participation)

I will not be receiving sedation through an IV for my procedure.

I will undergo anesthesia in a specialized medical setting.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-sedation

Participants receive either standardized pre-sedation instructions or a guided visualization exercise in addition to the instructions

1 day

1 visit (in-person)

Sedation and Surgery

Participants undergo sedation and oral/maxillofacial surgery with outcomes measured during and after the procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anesthesia-related outcomes and complete the Anesthesia Experience Survey

Within 2 hours post-surgery

Treatment Details

Interventions

• Guided visualization (Behavioral Intervention)

Trial Overview The study tests if adding a guided visualization exercise to standard pre-sedation instructions improves patient outcomes compared to just the instructions. Outcomes include patient experience, pain scores, medication use, and sedation duration.

Participant Groups

Group I: Guided visualization and standardized pre-sedation instructions group Experimental Treatment 1 Intervention

This arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.

Group II: Standardized pre-sedation instructions only group Placebo Group 1 Intervention

This group will receive the standardized pre-sedation instructions only, with no guided visualization.

Who Is Running the Clinical Trial?

Alameda Health System

Lead Sponsor

Trials

9

Recruited

4,100+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

Recent innovations in ultrasound-guided regional anesthesia, such as mechanical needle guides and compound imaging technology, enhance needle visibility and alignment, improving the accuracy of injections.

Techniques like sonoelastography and advancements in 3D and 4D ultrasound provide better tissue discrimination and fluid detection, which could lead to safer and more effective anesthesia practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Seeing more : Technical innovations in regional anesthesia]. Wiesmann, T., Steinfeldt, T., Volk, T., et al.[2018]

The study developed a mixed reality system using the Microsoft HoloLens to project a hologram of the ideal needle path for neuraxial anesthesia, which helps operators replicate the correct needle angulation during procedures.

Preliminary testing with both novice and experienced anesthesiologists showed that they could quickly learn to use this holographic guidance effectively on lumbar spine phantoms, indicating potential for improved accuracy in real procedures, although further research is needed to assess safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Head-Mounted Holographic Needle Guidance System for Enhanced Ultrasound-Guided Neuraxial Anesthesia: System Development and Observational Evaluation. Tanwani, J., Alam, F., Matava, C., et al.[2022]

The development of an augmented reality (AR) guidance system for anesthetic nerve blocks significantly improved needle placement accuracy, achieving a mean deviation of only 0.57 mm from target locations compared to 5.77 mm with traditional ultrasound alone.

This AR system, when combined with real-time ultrasound and tracked tools, has the potential to reduce the need for radiation-based imaging techniques like CT and fluoroscopy, thereby lowering radiation exposure for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guidance for spinal facet injections using tracked ultrasound. Moore, J., Clarke, C., Bainbridge, D., et al.[2019]

Ultrasound guidance in regional anesthesia allows for better visualization of needle placement and the spread of local anesthetics, which can help reduce the required volume of anesthetic needed for effective surgical anesthesia.

Studies indicate that using ultrasound guidance can lead to a decrease in local anesthetic dosage compared to traditional methods like blind or electrical nerve stimulation techniques, although the exact minimum effective dose for each block remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimum anesthetic volume in regional anesthesia by using ultrasound-guidance. Di Filippo, A., Falsini, S., Adembri, C.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reporting critical incidents in a tertiary hospital: a historical cohort study of 110,310 procedures. [2018]

2. France pubmed.ncbi.nlm.nih.gov

Outcomes from wake up safe, the pediatric anesthesia quality improvement initiative. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Medication Errors in Pediatric Anesthesia: A Report From the Wake Up Safe Quality Improvement Initiative. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A multisite validity study of self-reported anesthesia outcomes. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Initial results from the National Anesthesia Clinical Outcomes Registry and overview of office-based anesthesia. [2014]

6. Germany pubmed.ncbi.nlm.nih.gov

[Seeing more : Technical innovations in regional anesthesia]. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Development of a Head-Mounted Holographic Needle Guidance System for Enhanced Ultrasound-Guided Neuraxial Anesthesia: System Development and Observational Evaluation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided regional anesthesia: how much practice do novices require before achieving competency in ultrasound needle visualization using a cadaver model. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Image guidance for spinal facet injections using tracked ultrasound. [2019]

10. Brazil pubmed.ncbi.nlm.nih.gov

Minimum anesthetic volume in regional anesthesia by using ultrasound-guidance. [2017]