Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomize… (NCT03453359) | Clinical Trial Compass
CompletedNot Applicable
Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial
Spain180 participantsStarted 2018-01-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.