Status:
COMPLETED
Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial
Lead Sponsor:
Hospital Galdakao-Usansolo
Conditions:
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 characteristi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03453359
Start Date
January 28 2018
End Date
June 30 2020
Last Update
November 7 2023
Active Locations (1)
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1
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, Spain, 48960