Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors (ERGE)

Zhangjie Yu

Status: Enrolling

Conditions: Remimazolam Besylate; Gastrointestinal Endoscopy; Euphoria

Treatments: Drug: Remimazolam for Gastrointestinal Endoscopy Sedation

Study type: Observational

Funder types: Other

Identifiers

NCT06721195

LY2024-174-B

Details and patient eligibility

About

This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. This cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.

Enrollment: 305 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

305 participants in 1 patient group

Remimazolam Sedation Group

Description:

his cohort includes patients undergoing painless gastrointestinal endoscopy (gastroscopy, colonoscopy, or both) who receive sedation with remimazolam. The study aims to evaluate the incidence of euphoria induced by remimazolam and explore related factors. All patients receive sedation according to standard clinical guidelines, including pre-procedural sufentanil and lidocaine gel for oral preparation, followed by remimazolam for induction and maintenance. Data collected include demographic characteristics, pre- and post-procedure euphoria scores assessed using the ARCI-MBG scale, perioperative safety indicators, and patient satisfaction.

Treatment:

Drug: Remimazolam for Gastrointestinal Endoscopy Sedation