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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03995134
Ethics application status
Date submitted
17/06/2019
Date registered
21/06/2019

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
Other interventions - 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.


Other interventions: Propofol and Remifentanil administered by TCI pump
Propofol, Remifentanil, Alaris PK (pharmacokinetic) infusion pump with TCI
Intervention code [1] 0 0
Other interventions
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Upon completion of the study and publication, resulting data, study protocol and other information will be shared.

Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
Upon completion of study and publication
Available to whom?
Study protocol, and clinical report
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03995134