Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial

NCT03453359 | Completed DMC

• 1 other identifier: 01/18
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to determine the rate sedation-induced adverse events, comparing BIS-guided sedation with clinical observation. Secondary outcomes were to examine patient characteristics who developed adverse events, propofol and remifentanil dosage and patient satisfaction analyzing different time points undergoing elective colonoscopy.

Conditions

Colonoscopy

Keywords

bispectral index monitor; sedation; adverse effects

Outcome Measures

Primary Outcomes (1)

• Sedation-induced adverse events

  Compare the rate of cardiorrespiratory adverse events between the two groups

  1 year.

Secondary Outcomes (3)

• Characteristics of patients who developed adverse events

  1 year.

• The pharmacological dosage

  1 year.

• Level of satisfaction with the colonoscopy.

  1 year.

Study Arms (2)

BIS

EXPERIMENTAL

Group of patients (90) in whom sedation is adjusted using as main parameters the information obtained by the BIS sedation monitor (BIS VISTA, Aspect Medical Systems, USA).

Device: BIS monitor

Ramsay

ACTIVE COMPARATOR

Group of patients (90) in whom sedation is based on subjective monitoring of the level of sedation, using the Ramsay scale as a reference.

Device: Ramsay scale

Interventions

BIS monitor DEVICE

The investigators will place on the forehead of all patients the sensor BIS quatroTM, that connects with this monitor, and they will guide sedation and will record the values obtained.

Also known as: BIS VISTA; Aspect Medical Systems, USA

BIS

Ramsay scale DEVICE

In this group, sedation is guided by the Ramsay monitoring scale. The investigators will talk with the patients and will determine the corresponding level of sedation.

Also known as: Conventional monitoring

Ramsay

Eligibility Criteria

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

You may qualify if:

• Indication of complete colonoscopy on a scheduled basis.
• Classification of physical status ASA I, II and III, with the exception of patients with moderate to severe kidney and / or liver disease.
• Intermittent or persistent mild asthma. It implies the absence of daily symptoms and FEV1\> 80% (GINA 2004).
• Body Mass Index (BMI) less than 35 kg / m2, and greater than 18 kg/m2.
• Intact neurological capacity.
• Acceptance to participate in the study after the contribution of written informed consent.

You may not qualify if:

• ASA IV.
• BMI greater than 35 kg / m2, and less than 18 kg/m2.
• Refusal to participate in the study.
• Allergy to any of the medications used in sedation, or its components.
• Known mental or neurological disease.
• Renal and / or moderate to severe Hepatic insufficiency.
• Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
• Chronic opiate users.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

Location

Related Publications (12)

• Thomson A, Andrew G, Jones DB. Optimal sedation for gastrointestinal endoscopy: review and recommendations. J Gastroenterol Hepatol. 2010 Mar;25(3):469-78. doi: 10.1111/j.1440-1746.2009.06174.x.

  PMID: 20370725 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.

  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

• Hong MJ, Sung IK, Lee SP, Cheon BK, Kang H, Kim TY. Randomized comparison of recovery time after use of remifentanil alone versus midazolam and meperidine for colonoscopy anesthesia. Dig Endosc. 2015 Jan;27(1):113-20. doi: 10.1111/den.12383. Epub 2014 Nov 11.

  PMID: 25251893 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

• Sasaki T, Tanabe S, Azuma M, Sato A, Naruke A, Ishido K, Katada C, Higuchi K, Koizumi W. Propofol sedation with bispectral index monitoring is useful for endoscopic submucosal dissection: a randomized prospective phase II clinical trial. Endoscopy. 2012 Jun;44(6):584-9. doi: 10.1055/s-0032-1306776. Epub 2012 May 25.

  PMID: 22638779 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

• Qadeer MA, Vargo JJ, Patel S, Dumot JA, Lopez AR, Trolli PA, Conwell DL, Stevens T, Zuccaro G Jr. Bispectral index monitoring of conscious sedation with the combination of meperidine and midazolam during endoscopy. Clin Gastroenterol Hepatol. 2008 Jan;6(1):102-8. doi: 10.1016/j.cgh.2007.10.005. Epub 2007 Dec 11.

  PMID: 18065278 BACKGROUND

• Liu SS. Effects of Bispectral Index monitoring on ambulatory anesthesia: a meta-analysis of randomized controlled trials and a cost analysis. Anesthesiology. 2004 Aug;101(2):311-5. doi: 10.1097/00000542-200408000-00010.

  PMID: 15277912 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

• Oliveira CR, Bernardo WM, Nunes VM. Benefit of general anesthesia monitored by bispectral index compared with monitoring guided only by clinical parameters. Systematic review and meta-analysis. Braz J Anesthesiol. 2017 Jan-Feb;67(1):72-84. doi: 10.1016/j.bjane.2015.09.001. Epub 2016 Apr 14.

  PMID: 28017174 BACKGROUND

Study Officials

• Iratxe Gonzalez Mendibil, MD

  Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will be randomly assigned to one of the two study groups. The anesthesiologist who records the information knows which group they belong to, according to a randomization table provided in collaboration with the Research Unit, but the patients do not know it.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We compared the results of two groups of patients. Experimental group, in which sedation is adjusted using as main parameters the information obtained by the bispectral index monitor. Control Group, with sedation based on subjective monitoring using the Ramsay scale as a reference.

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: March 5, 2018
• Study Start: January 28, 2018
• Primary Completion: December 20, 2018
• Study Completion: June 30, 2020
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This study will begin in January 2018 and will end after the recruitment of the 180 patients and subsequent data analysis, approximately in June 2020.
• Access Criteria: The Principal Investigator has produced an Information Manual for collaborators where the protocol and the objectives of the study are detailed. This information has been sent via email and is printed and available in the endoscopy room where the registration will take place. The information folder includes the randomization table, informed consent, patient information sheet, data record sheet and record sheet for the BIS parameters of the patients in the Ramsay group. This information has been transmitted orally and an informative session has been held for all the members of the project. Members of the Research Unit will perform a check of this information, correlating it with what is described in the anesthesia chart and reviewing the patient data in the health system database. In addition, they will collaborate with the statistical analysis and obtaining results.

Locations

ES (1)