VR Sedation in Third Molar Surgery

May 9, 2023 updated by: Dr. Chan Chi-Wing, The University of Hong Kong

Sedation Sparing Effect of Virtual Reality in Third Molar Surgery

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR group
VR program will be displayed throughout the surgery.
Drug: Propofol
Targeted Controlled Propofol Infusion will be set at 1 micro gram/ml.
Placebo Comparator: Non-VR group
VR program will be turned off throughout the surgery.
Drug: Propofol
Targeted Controlled Propofol Infusion will be set at 1 micro gram/ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative propofol dose
Time Frame: From the start of anaesthesia to the end of anaesthesia, up to 2 hours after the start of surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW20-453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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