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

Launched by ZHANGJIE YU · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a medication called remimazolam affects feelings of euphoria during gastrointestinal endoscopy procedures, such as gastroscopy and colonoscopy. These procedures can often make patients feel uncomfortable or anxious, so the study aims to see if remimazolam can help improve patient comfort, cooperation, and overall satisfaction. The research is particularly focused on understanding the factors that might influence these feelings of euphoria, which could help doctors provide better sedation options in the future.

To be eligible for this study, participants need to be adults aged 18 to 65 who are scheduled for a routine, painless endoscopy lasting no more than 30 minutes. They should be in good health (classified as ASA I or II) and have a body mass index (BMI) between 18 and 28. However, individuals with a history of certain psychiatric disorders, substance abuse, or specific medical conditions, as well as pregnant or nursing women, will not be able to participate. Those who join the study can expect to receive remimazolam during their procedure and will be monitored for their comfort and feelings throughout the process.

Gender

ALL

Eligibility 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.