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

NCT03995134 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Propofol and Remifentanil administered by TCI pump

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

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Douglas Lobb, DDS · University of Alberta

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-03
Primary Completion
2020-01-17
Completion
2020-01-17

Countries

  • Canada
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03995134 on ClinicalTrials.gov