Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

Colonoscopy Clinical Trial

Official title:

Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461029
• Other study ID #: 01/16
• Status: Completed
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 5, 2018
• Start date: January 30, 2016
• Est. completion date: February 20, 2018

Study information

• Verified date: February 2018
• Source: Hospital Galdakao-Usansolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: February 20, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Galdakao-Usansolo	Galdakao	Vizcaya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Galdakao-Usansolo

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of sedation	Sedation measured by Bispectral Index Monitoring.	1 year.
Secondary	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.
Secondary	Level of satisfaction with the sedation.	The investigators distributed a satisfaction questionnaire to all patients after colonoscopy to find their opinion about the quality of sedation.	1 year.