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NCT04540666 Clinical Trial

VR Sedation in Third Molar Surgery

Anesthesia Clinical Trial

Official title:
Sedation Sparing Effect of Virtual Reality in Third Molar Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04540666
Other study ID # UW20-453
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 30, 2024

Study information
Verified date May 2023
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anaesthesia or sedation for dental surgery is Challenging. Over-sedation, leading to upper airway obstruction, desaturation and apnoea, is very common. On the other hand, it is also very common that inadequate sedative drugs were given, leading to under-sedation with unsatisfactory experience during operation. Therefore, it is good if some other methods are provided for sedation, avoiding side effects associated with sedative drugs.

Description:

Immersive virtual reality (VR) is a form of distraction therapy and is believed to create an immersive experience that can restrict the mind from pain and anxiety and has been shown to be superior to simple distraction in reducing pain.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date September 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Unilateral impacted lower third molar that requires surgical removal - Depth of impaction within 8mm as measured by Winter's line. - Cantonese speaking Exclusion Criteria: - ASA > III - BMI > 35 - Known Obstructive Sleep Apnoea - Patients with known or potential difficult airway - Chronic use of sedatives and opioid - Alcohol or drug abuse - Visual and hearing impairments - Claustrophobia - Cognitive impairment - History of seizure

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
Targeted Controlled Propofol Infusion will be set at 1 micro gram/ml.

Locations
Country Name City State
Hong Kong Queen Mary Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative propofol dose Amount of propofol required during surgery From the start of anaesthesia to the end of anaesthesia, up to 2 hours after the start of surgery
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