Target Controlled Infusion Using Propofol and Remifentanil for Moderate Sedation in Dentistry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Maintaining Patient Responsiveness during Target Controlled Infusion sedation
研究概览
简要总结
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.
详细描述
Purpose:
Moderate (conscious) sedation is a common pharmacological approach to managing psychological anxiety and physical pain associated with dental procedures including surgery. While maintaining patient responsiveness to verbal and tactile stimuli, safety of conducting moderate sedation in dental clinic is well documented with infrequent complications. Preferred drug choices for administering moderate intravenous (i.v.) sedation are midazolam (benzodiazepine sedative) and fentanyl (opioid analgesic) because their safety and efficacy have been well established and are currently considered the Standard of Care (SoC) worldwide.
The use of drugs intended for general anesthesia to provide moderate (conscious) sedation is increasingly being considered for dental sedation as there are a number of benefits when compared to the SoC. For example, propofol has a favorable pharmacokinetic profile and absence of lingering side-effects; drugs (propofol and remifentanil) with fast onset and offset times are most useful for balancing adequate hypnosis/analgesia with rapid recovery.
This clinical research study will explore the potential benefits of controlled administration of propofol (hypnotic agent) and remifentanil (opioid analgesic agent) utilizing two Target Controlled Infusion (TCI) pumps for moderate i.v. sedation by a sedationist/operator in a dental office-based environment.
Standardized care for moderate (conscious) sedation is guided by the following principle:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Maintaining Patient Responsiveness during Target Controlled Infusion sedation
时间窗: 5 minute
Number of participants with treatment-related adverse events as assessed by loss of consciousness or responsiveness
次要结局
- Patient recovery time(Up to 30 minutes)
- Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - oxygen desaturation(Baseline and 5 minute)
- Patient Satisfaction with TCI sedation(Questionnaire presented at baseline ( prior to discharge) and 24 to 48 hours post sedation)
- Rates of adverse events and side effects when using TCI for Procedural Sedation in Dentistry - heart rate(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)