Comparative Clinical Study of Cardiac and Respiratory Modifications Produced in Patients Undergoing Oral Surgery Through Local Anesthesia, Local Anesthesia and Oral Sedation With Midazolam, and Local Anesthesia Associated to Nitrous Oxide.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Systolic blood pressure change
研究概览
简要总结
The objective is to compare the changes produced in cardiological and respiratory parameters in three groups of patients undergoing oral surgery. The first group was treated with local anesthesia, a second group with local anesthesia plus oral conscious sedation with midazolam, and a third subject under anesthesia local with inhalation sedation with nitrous oxide.
A total of 90 non-cooperative phobic adult patients belonging to the group of patients of the University Master in Oral Surgery, Implantology and Periodontics of the University of León will be included in this study, after their information and acceptance of verbal and written consent, separated into three groups without significant differences in age, sex, smoking habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.
They will be randomly divided into three groups of 30 patients each. They will be given a prior consent both of the procedures to be performed and of the sedation procedure to which they will be subjected, if that is the case, without knowing what dose they will be administered. In case of being sedated, they will be informed verbally of the details concerning the procedure.
详细描述
A total of 90 non-cooperative phobic adult patients will be included in this study, after their information and acceptance of verbal and written consent, separated into three groups without significant differences in age, sex, smoking habits, cardiac or respiratory pathologies, and will be treated by advanced procedures of Oral Surgery, Periodontics and Implantology such as Sinus lift, Periodontal Surgeries and Implant Surgeries.
Initially, a complete health questionnaire will be filled out in all patients, and Partial Oxygen Saturation (SpO2), Respiratory Rate, Respiratory Volume in the form of Forced Vital Capacity (FVC), and also Forced Expiration Volume will be recorded as respiratory records (FEV) and Maximum Expiratory Flow (PEF), and as cardiac registers the Heart Rate, and the Systolic and Diastolic Blood Pressure before starting the procedure, records that will be repeated every 5 minutes during and until the end of it. The parameters will be recorded every 5 minutes, except for the parameters VFC, FEV1 and PEF that will be recorded exclusively at the beginning and at the end of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of phobic patients
- •Not having contraindications to be anesthetized or sedated, and
- •Present an acceptable state of health (ASA I and ASA II).
排除标准
- •Clinical conditions; ASA III, ASA IV and ASA V
结局指标
主要结局
Systolic blood pressure change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Systolic blood pressure change
Respiratory Rate change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Respiratory Rate change
Heart Rate change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Heart Rate change
Forced Vital Capacity (FVC) change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Forced Vital Capacity (FVC) change
Maximum Expiratory Flow (PEF) change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Maximum Expiratory Flow (PEF) change
Partial Oxygen Saturation (SpO2) change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Partial Oxygen Saturation (SpO2) change
Forced Expiration Volume (FEV) change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Forced Expiration Volume (FEV) change
Diastolic Blood Pressure change
时间窗: From the beginning of the sedation until the end, assessed Up to one hour
Diastolic Blood Pressure change
次要结局
未报告次要终点