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Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

NCT03461029 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 196

Last updated 2018-03-09

No results posted yet for this study

Summary

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).

Conditions

  • Colonoscopy

Interventions

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.

Sponsors & Collaborators

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • Iratxe Gonzalez Mendibil, MD · Hospital Galdakao-Usansolo

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-30
Primary Completion
2017-12-30
Completion
2018-02-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461029 on ClinicalTrials.gov