CompletedNot Applicable

Target Controlled Infusion Using Propofol and Remifentanil for Moderate Sedation in Dentistry

Canada, New Zealand101 participantsStarted 2019-08-03

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maintaining Patient Responsiveness during Target Controlled Infusion sedation

Timeframe: 5 minute

Trial details

NCT IDNCT03995134

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01-17

View on ClinicalTrials.gov More Sedative Adverse Reaction trials