Gastroscopic and Colonoscopic Sedation
Conditions
Brief summary
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained
Interventions
Remimazolam Tosilate for Injection
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation 2. Patients need to sign informed consent
Exclusion criteria
1. Patients who are participating in or planning to participate in any interventional clinical trial 2. The investigator considers that there are any other reasons for the patient's ineligibility for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Within 3 days of receiving gastroscopy and colonoscopy | Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | Within 3 days of receiving gastroscopy and colonoscopy | Refer to SAE definition standards |
| Adverse drug reactions | Within 3 days of receiving gastroscopy and colonoscopy | By evaluating the association of adverse events with drugs |
| Injection pain questionnaire | Within 3 days of receiving gastroscopy and colonoscopy | By observing and asking |
Countries
China
Outcome results
None listed