CClinicalTrials.gg
Active, not recruitingNCT04540666Updated May 10, 2023

VR Sedation in Third Molar Surgery

An interventional study of Propofol in Anesthesia, sponsored by The University of Hong Kong. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Anesthesia

Keywords

  • Anaesthesia for dental surgery
  • Sedation for dental surgery
03

In context

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    VR group

    VR program will be displayed throughout the surgery.

    Drug: Propofol

  • Placebo comparator
    Non-VR group

    VR program will be turned off throughout the surgery.

    Drug: Propofol

Interventions

  • DrugPropofol

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

06

What researchers measure

Primary outcomes

  1. Intraoperative propofol dose

    Amount of propofol required during surgery

    Time frame: From the start of anaesthesia to the end of anaesthesia, up to 2 hours after the start of surgery

07

Study locations

1 site
  • Queen Mary Hospital
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04540666
Lead sponsor
The University of Hong Kong
Responsible party
Dr. Chan Chi-Wing (Clinical Doctor, Consultant of Department of Anaesthesiology, Queen Mary Hospital; Principal Investigator, Honorary Clinical Associate Professor, Department of Anaesthesiology, The University of Hong Kong, The University of Hong Kong) — Principal investigator
First posted
Sep 7, 2020
Start date
Sep 1, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
May 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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