Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Level of sedation
研究概览
简要总结
The aim of the study is to establish and identify the level of sedation that is performed in the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS monitoring system, which obtains objective values in real time from the anesthesia performed. The monitoring is completed with basic parameters validated by European guidelines (heart rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay sedation scale, widely validated for use outside the operating room. The main work hypothesis was that in at least 10% of the patients BIS values compatible with moderate or deep sedation would be obtained (BIS <65).
详细描述
Observational study in patients undergoing scheduled colonoscopy in endoscopy rooms of the Galdakao-Usansolo Hospital. The investigators objectified the level of sedation that was performed in these procedures using Bispectral Index Monitoring, as well as the total dose of medication required and the level of satisfaction obtained after completing the sedation. The incidence of hemodynamic and respiratory complications observed was included, as well as the treatment needed to solve them.
A total of 196 patients were needed to obtain statistically significant results. Qualitative variables are expressed in the form of freguencies and percentages and continuous variables in the form of means and stnadard deviations. Comparisions of percentages were made by the Chi square test and the difference of means in the continuous variables by the t test.Stadistical significance will be assumed when p<0.05. All estadistical analyzes were carried out using SAS V9.4 (SAS Institute, Inc., Carey, NC).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication of scheduled colonoscopy.
- •Classification of physical status ASA I, II and III.
- •Intermitent or persistent mild asthma.
- •Body Mass Index (BMI) < 35 kg/m
- •Intact neurological capacity.
- •Acceptance to participate in the study after signing written informed consent.
排除标准
- •BMI > 35 kg/m
- •Allergy to any of the medications using in sedation, or its components.
- •Known mental or neurological disease.
- •Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
- •Chronic opiate users.
- •Refusal to participate in the study.
结局指标
主要结局
Level of sedation
时间窗: 1 year.
Sedation measured by Bispectral Index Monitoring.
次要结局
- Complications related to sedation.(1 year.)
- Level of satisfaction with the sedation.(1 year.)
研究者
Iratxe González Mendibil
Principal Investigator
Hospital Galdakao-Usansolo