CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 196 enrolled
Drug / intervention
BIS monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03461029
NCT03461029N/ACompleted

Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

Hospital Galdakao-Usansolo·observational·Posted Mar 9, 2018·Updated Mar 9, 2018

In Brief

An observational study evaluating BIS monitor for Colonoscopy. Completed, enrolled 196 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 9, 2018
Enrollment StartJan 30, 2016
Primary CompletionDec 30, 2017
Study CompletionFeb 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.3 years ago

Interventions

BIS monitordevice

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.