NCT04540666

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

August 27, 2020

Last Update Submit

May 9, 2023

Conditions

Anesthesia

Keywords

Anaesthesia for dental surgerySedation for dental surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

PropofolDRUG

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

Non-VR groupVR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral impacted lower third molar that requires surgical removal
  • Depth of impaction within 8mm as measured by Winter's line.
  • Cantonese speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Doctor, Consultant of Department of Anaesthesiology, Queen Mary Hospital; Principal Investigator, Honorary Clinical Associate Professor, Department of Anaesthesiology, The University of Hong Kong

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 7, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2023

Study Completion

September 30, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)