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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIS | Group of 196 patients in whom sedation monitoring is performed using the Bispectral Index Monitoring (BIS) system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of sedation | Sedation measured by Bispectral Index Monitoring. | 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications related to sedation. | Complications were measured: hypotension, bradicardia, apnea and low oxygen saturation. The medications or maneuvers that were necessary to correct these complications were also evaluated. | 1 year. |
| Level of satisfaction with the sedation. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from the general population, residents in the geographical area corresponding to the Hospital Galdakao Usansolo, who attended the endoscopy rooms. Were included to undergo a scheduled colonoscopy, either for monitoring, diagnostic or screening, and to meet the cited inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Iratxe Gonzalez Mendibil, MD | Hospital Galdakao-Usansolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Galdakao-Usansolo | Galdakao | Vizcaya | 48960 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26561915 | Background | Dumonceau JM, Riphaus A, Schreiber F, Vilmann P, Beilenhoff U, Aparicio JR, Vargo JJ, Manolaraki M, Wientjes C, Racz I, Hassan C, Paspatis G. Non-anesthesiologist administration of propofol for gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates Guideline--Updated June 2015. Endoscopy. 2015 Dec;47(12):1175-89. doi: 10.1055/s-0034-1393414. Epub 2015 Nov 12. No abstract available. | |
| 25048506 |
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The information contained in the study will be published once the review of the data included in it is completed. Previously, researchers will decide if the information contained is relevant for publication on this platform.
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The investigators distributed a satisfaction questionnaire to all patients after colonoscopy to find their opinion about the quality of sedation. |
| 1 year. |
| Background |
| Park WY, Shin YS, Lee SK, Kim SY, Lee TK, Choi YS. Bispectral index monitoring during anesthesiologist-directed propofol and remifentanil sedation for endoscopic submucosal dissection: a prospective randomized controlled trial. Yonsei Med J. 2014 Sep;55(5):1421-9. doi: 10.3349/ymj.2014.55.5.1421. |
| 23801836 | Background | Lera dos Santos ME, Maluf-Filho F, Chaves DM, Matuguma SE, Ide E, Luz Gde O, de Souza TF, Pessorrusso FC, de Moura EG, Sakai P. Deep sedation during gastrointestinal endoscopy: propofol-fentanyl and midazolam-fentanyl regimens. World J Gastroenterol. 2013 Jun 14;19(22):3439-46. doi: 10.3748/wjg.v19.i22.3439. |
| 23982208 | Background | Yu YH, Han DS, Kim HS, Kim EK, Eun CS, Yoo KS, Shin WJ, Ryu S. Efficacy of bispectral index monitoring during balanced propofol sedation for colonoscopy: a prospective, randomized controlled trial. Dig Dis Sci. 2013 Dec;58(12):3576-83. doi: 10.1007/s10620-013-2833-4. Epub 2013 Aug 28. |
| 19023932 | Background | Imagawa A, Fujiki S, Kawahara Y, Matsushita H, Ota S, Tomoda T, Morito Y, Sakakihara I, Fujimoto T, Taira A, Tsugeno H, Kawano S, Yagi S, Takenaka R. Satisfaction with bispectral index monitoring of propofol-mediated sedation during endoscopic submucosal dissection: a prospective, randomized study. Endoscopy. 2008 Nov;40(11):905-9. doi: 10.1055/s-2008-1077641. |
| 10922090 | Background | Bower AL, Ripepi A, Dilger J, Boparai N, Brody FJ, Ponsky JL. Bispectral index monitoring of sedation during endoscopy. Gastrointest Endosc. 2000 Aug;52(2):192-6. doi: 10.1067/mge.2000.107284. |