Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy (NCT06763705) | Clinical Trial Compass
CompletedPhase 4
Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy
Saudi Arabia183 participantsStarted 2025-06-15
Plain-language summary
This is a randomized, double-blinded, prospective study which will be conducted at the Department of Gastroenterology, King Saud Hospital, Unaizah, Qassim, Saudi Arabia. This study aims to compare safety and efficacy of different types of sedation medications for elective colonoscopy. Colonoscopy is a procedure to examine and visualize the colon by a fiberoptic tube called colonoscope. Sedation helps one to relax to avoid feel any discomfort or pain during the procedure.
Who can participate
Age range
18 Years – 60 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:
* Adults aged 18-60 years
* Both Genders
* Indication of colonoscopy procedure without advanced intervention
* American Society of Anesthesiologists (ASA) physical status I or II
* Competent to give informed consent
* Exclusion criteria:
* Personal history of allergic reaction or other contra-indications to midazolam, propofol or fentanyl
* Age below 18 or above 60 years
* Chronic use of benzodiazepines
* ASA physical status III or above
* Pregnancy
* History of smoking or alcohol abuse
* Body mass index \> 35 kg/m2
* History of airway obstruction or difficult intubation
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.
What they're measuring
1
Degree of sedation
Timeframe: every 3 minutes till the end of procedure
2
Onset of sedation
Timeframe: It will be measured every 1 minute till 20 minutes.
3
Adverse events and complication
Timeframe: Monitored continuously during procedure and post procedure for 2 hours and then up to 48 hours after discharge on telephone