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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03995134




Registration number
NCT03995134
Ethics application status
Date submitted
17/06/2019
Date registered
21/06/2019
Date last updated
23/01/2020

Titles & IDs
Public title
Target Controlled Infusion Using Propofol and Remifentanil for Moderate Sedation in Dentistry
Scientific title
Target Controlled Infusion Using Propofol and Remifentanil for Moderate Sedation in Dentistry
Secondary ID [1] 0 0
Pro00083505
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedative Adverse Reaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Combination Product - Propofol and Remifentanil administered by TCI pump

Propofol and Remifentanil - Procedural sedation in Dentistry provided by a Target Controlled Infusion pump using propofol as the sedative/hypnotic agent and Remifentanil as the opioid analgesic agent.


Combination Product: Propofol and Remifentanil administered by TCI pump
Propofol, Remifentanil, Alaris PK (pharmacokinetic) infusion pump with TCI
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maintaining Patient Responsiveness during Target Controlled Infusion sedation
Timepoint [1] 0 0
5 minute
Secondary outcome [1] 0 0
Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - oxygen desaturation
Timepoint [1] 0 0
Baseline and 5 minute
Secondary outcome [2] 0 0
Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - blood pressure
Timepoint [2] 0 0
Baseline and 5 minute
Secondary outcome [3] 0 0
Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - heart rate
Timepoint [3] 0 0
Baseline and 5 minute
Secondary outcome [4] 0 0
Patient Satisfaction with TCI sedation
Timepoint [4] 0 0
Questionnaire presented at baseline ( prior to discharge) and 24 to 48 hours post sedation
Secondary outcome [5] 0 0
Patient recovery time
Timepoint [5] 0 0
Up to 30 minutes

Eligibility
Key inclusion criteria
- Patient age: =18 years of age.

- Patients who are generally healthy (American Society of Anesthesiology [ASA] Physical
Status I), or patients with mild systemic disease (ASA Patient Physical Status II).

- Both genders eligible.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients who would normally be unsuitable candidates for treatment in non-hospital
dental facilities undergoing intravenous sedation.

- Medically complex or unwell patients who may require medical anesthesiologist or
hospital assistance, i.e., ASA III or greater.

- Patients with a history of anesthetic-related complications or difficult airway
management that may require the assistance of an anesthesiologist.

- Patients allergic to propofol or fentanyl compounds.

- Patients who are unable to, or refuse to sign the consent form.

- Female patients who are pregnant, or suspect they may be.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/01/2020
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this university study is to evaluate the use of an advanced dental sedation
technique involving two syringe-type pumps called Target Controlled Infusion (TCI) pumps. Two
oral surgeons and a general dentist from New Zealand are assisting a Canadian research team
as they study this intravenous sedation technique and its use in dental offices. This
sedation technique is broadly used in other parts of the world and is known to reduce anxiety
and discomfort during dental or medical procedures.

The New Zealand Dental Council and Health Canada have approved the drugs involved and the TCI
pumps. In this study, one pump will be used to administer a sedative drug called propofol and
the other to administer a pain-relief analgesic drug called remifentanil. The pumps and drugs
are licensed in New Zealand and Canada and are not experimental.

These pumps are operated by special software modules that are specific to each drug, and a
computer within the pump controls the pump operation allowing a stable and constant level of
drug in the blood stream.

Your oral surgeon or dentist will titrate or add small amounts of drug till the you are quite
relaxed before proceeding with your dental treatment. The dentist has overall control of the
pump and the amount of drug given and can change the amount if it is too little or too much
for you, or completely stop the pump if necessary for safety..

The TCI sedation, including your dental treatment will be conducted by two oral surgeons and
a general dentist in their respective New Zealand dental offices. Each clinician is well
trained and experienced with this form of sedation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03995134
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas Lobb, DDS
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03995134