Analgosedation for Elective Colonoscopy (NCT05421962) | Clinical Trial Compass
CompletedPhase 1
Analgosedation for Elective Colonoscopy
Bosnia and Herzegovina90 participantsStarted 2020-01-01
Plain-language summary
Aim: The aim of the study was to to compare the analgesic effects of ketamine over fentanyl combined with propofol in analgesia-based elective colonoscopy with purpose of patient safety and satisfaction.
Methods: This is a double-blinded prospective randomized controlled trial. Ninety patients were included and randomized to either fentanyl-propofol (Group FP, n: 30), ketamine-propofol (Group KP, n: 30) or propofol-control group (Group C, n: 30). Group FP patients received fentanyl and propofol, Group KP received ketamine and propofol and Group C, propofol. In all groups, incremental doses of propofol were used to maintain a Ramsay sedation score (RSS) of 5. Respiratory depression, hemodynamic parameters were monitored for the first minute and every 5 minutes during endoscopy. Fifteen minutes after the procedure, the degree of pain was assessed using a visual analog scale (VAS), the quality of recovery according to the Aldrete score (ARS), complications during and after the procedure and additional doses of propofol were recorded.
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:
* ASA physical statuses I and II,
* patients who were older than 18 years
Exclusion Criteria:
* colonoscopies lasting longer than 30 minutes,
* patients with previous abdominal surgery,
* patients treated for neuropathic pain, malignant and respiratory diseases,
* pregnant women, gastrointestinal obstruction,
* patients using antihypertensive and antiarrhythmic drugs,
* psychiatric patients,
* patients with ASA physical status III and higher,
* patients who refused to participate in the study
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.