Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT06721195
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06721195
Study Brief:
Protocol Section:
NCT06721195