VR Sedation in Third Molar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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VR group

VR program will be displayed throughout the surgery.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Non-VR group

VR program will be turned off throughout the surgery.

Group Type PLACEBO_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR