Bispectral Index and Clinical Parameters Evaluation in Different Dental Procedures With Nitrous Oxide and Oxygen Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- BIS value
研究概览
简要总结
BACKGROUND: The degree of consciousness during nitrous oxide use is still a matter of concern for both dentists and anesthesiologists. Investigators hypothesized that BIS levels do not vary according nitrous oxide concentration during minimum to moderate sedation in the dental treatment.
METHODS: One hundred patients undergoing dental procedures demanding local anesthesia (1.8 mL of 2% lidocaine with 1:100.000 epinephrine) were enrolled in this study. Initial pain and anxiety were measured by 11-point numerical and anxiety visual scales, respectively. Systolic/diastolic arterial blood pressure, SpO2, heart and respiratory rates, and psychomotor ability (Trieger test) were assessed before, during and after dental treatment. Sedation levels were evaluated by both BIS and sedation analogic scale at the same intervals. The duration of treatment along with nitrous oxide concentration and side effects were observed. Kruskal-Wallis, Friedman and Mann-Whitney tests were used (alpha=5%).
详细描述
One-hundred ASA I / II volunteers of both genders were selected in different dental speciality clinics (restorative dentistry, endodontics, implantology, and oral surgery) of Dental Institute of Pontifical Catholic University of Rio de Janeiro PUC-Rio).
After anamnesis and obtaining written informed consent, all volunteers were asked to fill an 11-point numerical scale in order to quantify the initial pain. The scale showed 0 as "no pain" and 10 as the "worst pain imaginable". In addition, volunteers were also asked to fill a facial image scale in order to determine the initial anxiety. This scale showed four levels: 0 corresponding to absolutely calm; 1 - slightly stressed; 2 - stressed; and 3 - extremely stressed.
The volunteers were positioned in the dental chair and instructed to fill a Trieger test (psychomotor evaluation) during the following periods: 1) before sedation; 2) during the sedation (10 minutes after respiratory stabilization with N2O/O2); and 3) 10 minutes after the end of sedation. The number of wrong connected points (precision) and the time required to fill all points were used to estimate psychomotor ability.
A pulse oxymeter was placed in the volunteers' thumb and an electronic sphygmomanometer was positioned in the forearm in order to evaluate oxygen saturation (SpO2), systolic and diastolic pressures, and hearth rate during the same moments of the Trieger test. Respiratory rate was evaluated at same moments, by direct observation of thoracic movements.
The electrodes of BIS monitor were placed and the values were obtained at same operatory periods previously described, despite the continuous BIS monitoring. After BIS-signal stabilization, the dental procedure and the sedation with N2O/O2 were explained to the volunteer. Two previously calibrated operators installed BIS electrodes, applied the Trieger test and sedated all subjects. A third operator performed the dental treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender;
- •Age from 18 to 60 years;
- •Needing one or more specialized treatment, such as restorative dentistry, endodontics, implantology, or oral surgery.
排除标准
- •Compulsive personality;
- •Claustrophobia;
- •Severe personal disorders;
- •Chronic obstructive pulmonary diseases;
- •Recent ear surgery history;
- •Use of bleomycin during the last year;
- •Use of CNS depressants;
- •Use of analgesics or anti-inflammatory agents one week before the study;
- •Former drug addicts;
- •Pregnancy.
研究组 & 干预措施
Nitrous oxide
Nitrous oxide sedation
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
BIS value
时间窗: two hours
Relative values continuously registered by the BIS device
次要结局
- Blood Pressure(two hours)
- Trieger test(two hours)
- Pain(two hours)
- Anxiety(two hours)
- Heart rate(two hours)
- Respiratory Frequency (RF)(two hours)
研究者
Francisco Groppo
Professor
University of Campinas, Brazil