Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

March 5, 2018 updated by: Iratxe González Mendibil, Hospital Galdakao-Usansolo
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational study in patients undergoing scheduled colonoscopy in endoscopy rooms of the Galdakao-Usansolo Hospital. The investigators objectified the level of sedation that was performed in these procedures using Bispectral Index Monitoring, as well as the total dose of medication required and the level of satisfaction obtained after completing the sedation. The incidence of hemodynamic and respiratory complications observed was included, as well as the treatment needed to solve them.

A total of 196 patients were needed to obtain statistically significant results. Qualitative variables are expressed in the form of freguencies and percentages and continuous variables in the form of means and stnadard deviations. Comparisions of percentages were made by the Chi square test and the difference of means in the continuous variables by the t test.Stadistical significance will be assumed when p<0.05. All estadistical analyzes were carried out using SAS V9.4 (SAS Institute, Inc., Carey, NC).

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

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

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BIS
Group of 196 patients in whom sedation monitoring is performed using the Bispectral Index Monitoring (BIS) system.
Device: BIS monitor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of sedation
Time Frame: 1 year.
Sedation measured by Bispectral Index Monitoring.
1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications related to sedation.
Time Frame: 1 year.
Complications were measured: hypotension, bradicardia, apnea and low oxygen saturation. The medications or maneuvers that were necessary to correct these complications were also evaluated.
1 year.
Level of satisfaction with the sedation.
Time Frame: 1 year.
The investigators distributed a satisfaction questionnaire to all patients after colonoscopy to find their opinion about the quality of sedation.
1 year.

Collaborators and Investigators

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

Sponsor

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 30, 2016

Primary Completion (ACTUAL)

December 30, 2017

Study Completion (ACTUAL)

February 20, 2018

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (ACTUAL)

March 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The information contained in the study will be published once the review of the data included in it is completed. Previously, researchers will decide if the information contained is relevant for publication on this platform.

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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