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

November 2, 2023 updated by: Iratxe González Mendibil, Hospital Galdakao-Usansolo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Galdakao-Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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.
Other Names:
  • BIS VISTA; Aspect Medical Systems, USA
Active Comparator: 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.
Device: 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 Names:
  • Conventional monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation-induced adverse events
Time Frame: 1 year.
Compare the rate of cardiorrespiratory adverse events between the two groups
1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of satisfaction with the colonoscopy.
Time Frame: 1 year.
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.
Characteristics of patients who developed adverse events
Time Frame: 1 year.
Describe the patient characteristics
1 year.
The pharmacological dosage
Time Frame: 1 year.
The investigators will note if there is significant differences in the dose of phamacological drugs, and rescue propofol
1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Galdakao-Usansolo

Investigators

  • Principal Investigator: Iratxe Gonzalez Mendibil, MD, Hospital Galdakao-Usansolo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2018

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

January 27, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators have a randomization table to assign the intervention of each patient. The investigators will record anthropometric data and the parameters resulting from the monitoring. These data will be available to collaborating investigators and subsequently to a member of the Research Unit who will record this information in a database that will be analyzed to obtain results.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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