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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995134
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment
Sedative Adverse Reaction Combination Product: Propofol and Remifentanil administered by TCI pump

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
New Zealand citizens
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Alberta
Dr. Douglas Lobb
Edmonton, Alberta, Canada, T5N 4A3
New Zealand
Dr. Don Macalister
Auckland, New Zealand
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Douglas Lobb, DDS University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03995134    
Other Study ID Numbers: Pro00083505
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon completion of the study and publication, resulting data, study protocol and other information will be shared.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Upon completion of study and publication
Access Criteria: Study protocol, and clinical report

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Alberta:
Use of propofol and remifentanil administered with TCI pump
Additional relevant MeSH terms:
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Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents