Target Controlled Infusion Using Propofol and Remifentanil for Moderate Sedation in Dentistry
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|ClinicalTrials.gov Identifier: NCT03995134|
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : January 23, 2020
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.
|Condition or disease||Intervention/treatment|
|Sedative Adverse Reaction||Combination Product: Propofol and Remifentanil administered by TCI pump|
|Study Type :||Observational|
|Actual Enrollment :||101 participants|
|Official Title:||Target Controlled Infusion Using Propofol and Remifentanil for Moderate Sedation in Dentistry|
|Actual Study Start Date :||August 3, 2019|
|Actual Primary Completion Date :||January 17, 2020|
|Actual Study Completion Date :||January 17, 2020|
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
- Maintaining Patient Responsiveness during Target Controlled Infusion sedation [ Time Frame: 5 minute ]Number of participants with treatment-related adverse events as assessed by loss of consciousness or responsiveness
- Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - oxygen desaturation [ Time Frame: Baseline and 5 minute ]Sum of time intervals of oxygen desaturation below SpO2 of 90.
- Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - blood pressure [ Time Frame: Baseline and 5 minute ]A change of Mean Arterial Pressure (MAP) of more than 25% from baseline
- Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - heart rate [ Time Frame: Baseline and 5 minute ]A change in the heart rate of more than 25% from baseline
- Patient Satisfaction with TCI sedation [ Time Frame: Questionnaire presented at baseline ( prior to discharge) and 24 to 48 hours post sedation ]Use of a patient recall and satisfaction questionnaire as a non-technical outcome measure provides researcher/stakeholders with important information on patient's experiences and perspectives
- Patient recovery time [ Time Frame: Up to 30 minutes ]Measure of time to discharge as defined by the time from last drug administered until patient meets discharge criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995134
|Dr. Douglas Lobb|
|Edmonton, Alberta, Canada, T5N 4A3|
|Dr. Don Macalister|
|Auckland, New Zealand|
|Principal Investigator:||Douglas Lobb, DDS||University of Alberta|