Investigating Euphoria from Remimazolam During Gastrointestinal Endoscopy
A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors
RenJi Hospital · NCT06721195
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 |
|---|---|
| Enrollment | 305 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06721195 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Euphoria, Remimazolam Besylate, Gastrointestinal Endoscopy