Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gast… (NCT07613073) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy
Vietnam1,000 participantsStarted 2026-05-15
Plain-language summary
This prospective observational cohort study will evaluate the incidence and independent predictors of clinically relevant hypotension and hypoxemia during propofol-based diagnostic gastrointestinal endoscopy in adult patients at a tertiary referral hospital in Vietnam. Participants undergoing diagnostic upper gastrointestinal endoscopy, colonoscopy, or combined diagnostic procedures with propofol administration will be followed from pre-procedure assessment through the early recovery period. The study will assess demographic, clinical, airway, procedural, and sedation-related variables associated with clinically relevant cardiopulmonary adverse events.
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:
* Age 18 years or older
* Scheduled for diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy
* Planned use of propofol as the primary sedative/anesthetic agent for diagnostic gastrointestinal endoscopy
* American Society of Anesthesiologists physical status I to III
* Able to provide informed consent or has legally authorized representative consent according to local regulations
Exclusion Criteria:
* Therapeutic or interventional gastrointestinal endoscopy, including ERCP, EUS-guided intervention, EMR, ESD, endoscopic hemostasis, or polypectomy
* Planned sedation/anesthesia without propofol as the primary sedative/anesthetic agent
* Known allergy or contraindication to propofol
* Pregnancy or suspected pregnancy
* Emergency condition requiring immediate advanced airway control before the procedure
* Inability to obtain essential baseline or outcome data required for 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.
What they're measuring
1
Number of Participants With Clinically Relevant Hypotension
Timeframe: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
2
Number of Participants With Clinically Relevant Hypoxemia
Timeframe: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.