Hospital Galdakao-Usansolo
Galdakao, Vizcaya, 48960, Spain
NCT Number: NCT03461029
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).
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Notify Me18 year–80 year
All sexes
Observational
Galdakao, Vizcaya, 48960, Spain
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigators placed on the forehead of all patients the sensor BIS quatroTM, that connects with the monitor, and they registered sedation and recorded the values obtained.
Time frame: 1 year.
Sedation measured by Bispectral Index Monitoring.
Time frame: 1 year.
Complications were measured: hypotension, bradicardia, apnea and low oxygen saturation. The medications or maneuvers that were necessary to correct these complications were also evaluated.
Time frame: 1 year.
The investigators distributed a satisfaction questionnaire to all patients after colonoscopy to find their opinion about the quality of sedation.
Hospital Galdakao-Usansolo
Other Gov
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