Clinical trial NCT03461029: Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
Official title: Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Keywords: Sedation
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
First posted: 2018-03-09
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Indication of scheduled colonoscopy.
* Classification of physical status ASA I, II and III.
* Intermitent or persistent mild asthma.
* Body Mass Index (BMI) \< 35 kg/m2.
* Intact neurological capacity.
* Acceptance to participate in the study after signing written informed consent.

Exclusion Criteria:

* ASA IV.
* BMI \> 35 kg/m2.
* 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.

Primary outcomes:
measure: Level of sedation
timeFrame: 1 year.
Secondary outcomes:
measure: Complications related to sedation.
timeFrame: 1 year.
measure: Level of satisfaction with the sedation.
timeFrame: 1 year.
Other outcomes:
Locations:
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
Study officials:
affiliation: Hospital Galdakao-Usansolo
name: Iratxe Gonzalez Mendibil, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.