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

Colonoscopy Clinical Trial

— BIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453359
• Other study ID #: 01/18
• Status: Completed
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2023
• Source: Hospital Galdakao-Usansolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized double-blind clinical trial in patients undergoing scheduled colonoscopies in endoscopy rooms of the Galdakao-Usánsolo Hospital (Bizkaia, Spain) and Mendaro Hospital (Gipuzkoa, Spain). The investigators will compare the rate of cardiorrespiratory adverse events as well as the anesthetic drugs dosage, need for rescue medication and patient satisfaction among the experimental group in which sedation is guided by BIS and the control group in which the anesthesiologist is blind to the result of the BIS. The investigators hypothesized that BIS monitoring would be associated with better outcomes than clinical observation.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 30, 2020
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Device:
• 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.

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 (12)

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. — View Citation

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. — View Citation

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. — 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. doi: 10.1055/s-2008-1077641. — 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

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — 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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation-induced adverse events	Compare the rate of cardiorrespiratory adverse events between the two groups	1 year.
Secondary	Characteristics of patients who developed adverse events	Describe the patient characteristics	1 year.
Secondary	The pharmacological dosage	The investigators will note if there is significant differences in the dose of phamacological drugs, and rescue propofol	1 year.
Secondary	Level of satisfaction with the colonoscopy.	The investigators will distribute a satisfaction questionnaire to all patients after the colonoscopy to find out their opinion about the quality of sedation.	1 year.