Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial
NCT ID: NCT03453359
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
180 participants
INTERVENTIONAL
2018-01-28
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
NCT03461029
Effect of Bispectral Index Monitoring (BIS) on Body Movement of Outpatients Undergoing Gastroscopy
NCT05773807
Bronchoscopy and Bispectral Index (BIS) - Guided Sedation
NCT00839371
The Influence of Age on Bispectral Index Associated With Propofol-induced Sedation
NCT02046720
ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care
NCT05340335
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The BIS is the parameter of anesthetic depth monitoring most used today. Its use was approved by the Food and Drug Administration (FDA) in 1996 as an aid to control the effects of certain anesthetic agents. It is validated in the operating room (Recommendation grade A), but not outside it due to lack of conclusive studies.
180 patients are needed to obtain statistically significant differences between both groups. Qualitative variables are expressed in the form of frequencies and percentages and continuous variables in the form of means and standard deviations. Comparisons of percentages will be made by the Chi square test (or Exact Fisher's test, when the expected frequencies are less than 5) and the difference of means in the continuous variables by the t test as well as by the Wilcoxon nonparametric test if the distribution of the variable requires it. The degree of agreement between the BIS and Ramsay scale will be made through the weighted Kappa test. Statistical significance will be assumed when p \<0.05. All statistical analyzes will be carried out using SAS V9.4. (SAS institute, Inc., Carey, NC).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIS
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).
BIS monitor
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.
Ramsay
Group of patients (90) in whom sedation is based on subjective monitoring of the level of sedation, using the Ramsay scale as a reference.
Ramsay scale
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIS monitor
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.
Ramsay scale
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Galdakao-Usansolo
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Iratxe González Mendibil
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Iratxe Gonzalez Mendibil, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Galdakao-Usansolo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01/18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.