VR Sedation in Third Molar Surgery | NCT04540666

Studies
VR Sedation in Third Molar Surgery

NCT04540666

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

May 10, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Propofol

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Aug 27, 2020

First Submission Date that Met QC Criteria

Aug 31, 2020

First Posted Date

Sep 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2023

Last Update Posted Date

May 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VR group	Experimental	VR program will be displayed throughout the surgery.	Drug: Propofol
Non-VR group	Placebo Comparator	VR program will be turned off throughout the surgery.	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	Targeted Controlled Propofol Infusion will be set at 1 micro gram/ml.	Non-VR group VR group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital		Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

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Browse Branches

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