Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (NCT07702240) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP
530 participantsStarted 2026-07-10
Plain-language summary
This study compares two anesthesia medications, esketamine and sufentanil, used together with propofol during ERCP procedures. The goal is to find out which combination provides better safety and comfort for people undergoing ERCP.
Participants will be randomly assigned to receive either esketamine or sufentanil during sedation. Researchers will monitor blood oxygen levels, blood pressure, and recovery time during and after the procedure to evaluate safety and effectiveness.
Who can participate
Age range
18 Years – 90 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 years
* Patients scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP)
* American Society of Anesthesiologists (ASA) physical status I-III
* Body mass index (BMI) between 18.5 and 30 kg/m²
* Patients requiring sedation for ERCP
* Ability to provide written informed consent voluntarily
Exclusion Criteria:
* Allergy or contraindication to propofol, esketamine, sufentanil, or related medications
* Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
* Severe dysfunction of the heart, lungs, liver, or kidneys
* History of central nervous system disorders or psychiatric disorders
* Anticipated difficult airway
* History of psychiatric disorders or contraindications to ketamine use
* Inability to communicate or provide informed consent
* Requirement for general anesthesia with endotracheal intubation or intraoperative conversion to general anesthesia with 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
Incidence of intraoperative hypoxemia
Timeframe: Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.