CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
BIS monitor +1 moredevice
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/NCT03453359
NCT03453359N/ACompleted
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Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial

Hospital Galdakao-Usansolo·interventional·Posted Mar 5, 2018·Updated Nov 7, 2023

In Brief

A clinical study evaluating BIS monitor and Ramsay scale for Colonoscopy. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 5, 2018
Enrollment StartJan 28, 2018
Primary CompletionDec 20, 2018
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.3 years ago

Interventions

BIS monitordevice

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 scaledevice

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.