Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

• ClinicalTrials.gov Identifier: NCT03461029
• Recruitment Status: Completed
• First Posted: March 9, 2018
• Last Update Posted: March 9, 2018
• Sponsor: Hospital Galdakao-Usansolo
• Information provided by (Responsible Party): Iratxe González Mendibil, Hospital Galdakao-Usansolo

Study Description

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).

Condition or disease	Intervention/treatment
Colonoscopy	Device: BIS monitor

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).

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 196 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Year
• Official Title: Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
• Actual Study Start Date: January 30, 2016
• Actual Primary Completion Date: December 30, 2017
• Actual Study Completion Date: February 20, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
BIS; Group of 196 patients in whom sedation monitoring is performed using the Bispectral Index Monitoring (BIS) system.	Device: BIS monitor; 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.

Outcome Measures

Primary Outcome Measures :

1. Level of sedation [ Time Frame: 1 year. ]
   Sedation measured by Bispectral Index Monitoring.

Secondary Outcome Measures :

1. Complications related to sedation. [ 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.
2. Level of satisfaction with the sedation. [ Time Frame: 1 year. ]
   The investigators distributed a satisfaction questionnaire to all patients after colonoscopy to find their opinion about the quality of sedation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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.

Contacts and Locations

Locations

Spain

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, Spain, 48960

Sponsors and Collaborators

Hospital Galdakao-Usansolo

Investigators

• Principal Investigator: Iratxe Gonzalez Mendibil, MD; Hospital Galdakao-Usansolo

More Information

Additional Information:

Publications:

Dumonceau JM, Riphaus A, Schreiber F, Vilmann P, Beilenhoff U, Aparicio JR, Vargo JJ, Manolaraki M, Wientjes C, Rácz 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.

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.

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.

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.

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.

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.

• Responsible Party: Iratxe González Mendibil, Principal Investigator, Hospital Galdakao-Usansolo
• ClinicalTrials.gov Identifier: NCT03461029
• Other Study ID Numbers: 01/16
• First Posted: March 9, 2018
• Last Update Posted: March 9, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Iratxe González Mendibil, Hospital Galdakao-Usansolo:

Sedation