Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

NCT03461029 | Completed DMC

• 1 other identifier: 01/16
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

Colonoscopy

Keywords

Sedation

Outcome Measures

Primary Outcomes (1)

• Level of sedation

  Sedation measured by Bispectral Index Monitoring.

  1 year.

Secondary Outcomes (2)

• Complications related to sedation.

  1 year.

• Level of satisfaction with the sedation.

  1 year.

Study Arms (1)

BIS

Group of 196 patients in whom sedation monitoring is performed using the Bispectral Index Monitoring (BIS) system.

Device: BIS monitor

Interventions

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.

BIS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

Location

Related Publications (6)

• 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.

  PMID: 26561915 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.

  PMID: 25048506 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.

  PMID: 23801836 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.

  PMID: 23982208 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.

  PMID: 19023932 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.

  PMID: 10922090 BACKGROUND

Study Officials

• Iratxe Gonzalez Mendibil, MD

  Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 9, 2018
• Study Start: January 30, 2016
• Primary Completion: December 30, 2017
• Study Completion: February 20, 2018
• Last Updated: March 9, 2018

Record last verified: 2018-02

Locations

ES (1)