Investigating Euphoria from Remimazolam During Gastrointestinal Endoscopy
Official title: A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors
Run by RenJi Hospital · NCT06721195 · Data updated 2026-11-12
This study is testing if a medication called remimazolam makes patients feel good and more comfortable during gastrointestinal procedures like endoscopies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 305 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | October 31, 2024 |
| Study ends | December 31, 2024 |
| Registry record updated | December 6, 2024 |
| Trial ID | NCT06721195 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 65 scheduled for routine painless gastrointestinal endoscopy with an ASA physical status classification of I or II.
✕Probably not a fit
Patients with a history of psychiatric disorders, severe hepatic or renal disease, or those requiring complex endoscopic procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy procedures, such as gastroscopy and colonoscopy. It will explore various factors related to patient comfort, cooperation, and satisfaction while using remimazolam, a short-acting benzodiazepine known for its rapid onset and controlled effects. By evaluating these parameters, the study seeks to optimize sedation protocols and enhance clinical outcomes for patients undergoing these procedures.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices that enhance patient comfort and satisfaction during gastrointestinal endoscopy.
How similar studies have gone: While the specific focus on euphoria from remimazolam during endoscopy is novel, similar studies on sedation practices have shown promising results in improving patient experiences.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 65 years, regardless of gender. * Patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both. * ASA physical status classification: I or II. * BMI between 18 kg/m² and 28 kg/m². * Anticipated procedural duration of no more than 30 minutes. * Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks. Exclusion Criteria: * History of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse. * Known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines. * Patients requiring complex endoscopic procedures (e.g., ERCP, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy). * History of severe hepatic or renal disease. * Pregnant or lactating women. * Participation in another clinical study within the past three months. * Any condition or factor that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Where it's running
-
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Zhangjie Yu, M.Sc.
- Email: novo8yu@gmail.com
- Phone: 0086-13761067441
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Music during endoscopy to reduce sedative need
This study tests whether listening to low-tempo instrumental music during gastroscopy and/or colonoscopy can lessen the amount of sedative medication needed.
-
SED Pack: Predictive monitoring tool for sedation during GI endoscopy
A software tool called SED Pack is being tested to see if it can better predict how patients will respond to sedation during GI endoscopy in adults.
-
Remimazolam sedation in ICU patients on mechanical ventilation
This study tests whether using remimazolam for sedation helps mechanically ventilated ICU patients recover better compared to another sedative.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.