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

NCT03995134 | Completed

• 1 other identifier: Pro00083505
• Study Type: observational
• Target: 101
• Locations: 2 countries
• Sites: 2

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.

Conditions

Sedative Adverse Reaction

Keywords

Use of propofol and remifentanil administered with TCI pump

Outcome Measures

Primary Outcomes (1)

• Maintaining Patient Responsiveness during Target Controlled Infusion sedation

  Number of participants with treatment-related adverse events as assessed by loss of consciousness or responsiveness

  5 minute

Secondary Outcomes (5)

• Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - oxygen desaturation

  Baseline and 5 minute

• Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - blood pressure

  Baseline and 5 minute

• Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - heart rate

  Baseline and 5 minute

• Patient Satisfaction with TCI sedation

  Questionnaire presented at baseline ( prior to discharge) and 24 to 48 hours post sedation

• Patient recovery time

  Up to 30 minutes

Study Arms (1)

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

Interventions

Propofol and Remifentanil administered by TCI pump COMBINATION_PRODUCT

Propofol, Remifentanil, Alaris PK (pharmacokinetic) infusion pump with TCI

Propofol and Remifentanil

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New Zealand citizens

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

Dr. Douglas Lobb

Edmonton, Alberta, T5N 4A3, Canada

Location

Dr. Don Macalister

Auckland, New Zealand

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Douglas Lobb, DDS

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 21, 2019
• Study Start: August 3, 2019
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: September 19, 2024

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon completion of study and publication
• Access Criteria: Study protocol, and clinical report

Locations

NZ (1); CA (1)