Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to compare the safety and efficacy of remimazolam and propofol in EUS-FNA/FNB sedation. This study is a prospective, single-blind study. We plan to enroll 264 patients undergoing EUS-FNA and divide them into two groups. The experimental group was sedated with remimazolam, and the control group was sedated with propofol; safety and efficacy parameters such as intraoperative blood pressure, finger pulse oxygen, heart rate and sedation success rate would be compared. We hypothesized that patients in the experimental group would be superior in terms of safety parameters; the two would be equal in terms of sedation success.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Third Xiangya Hospital of Central South University
• Treatments: Propofol

Criteria

Inclusion Criteria:

1. Age: ≥18 years old and ≤75 years old

2. BMI: 18kg/m^23. Body weight: 40kg

4. Patients who intend and qualified to undergo sedated EUS-FNA/FNB.

5. Clearly understand, voluntarily participate in the research, and sign the informed consent form.

Exclusion Criteria:

1. Patients who are not suitable for sedated EUS-FNA/FNB for any reason (e.g. cardiovascular disease)

2. Patients have abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN;

3. Patients have abnormal renal function, urea or blood urea nitrogen≥1.5×ULN, serum creatinine≥1.0 ×ULN

4. Those who are allergic to benzodiazepines, opioids, propofol or lidocaine.

5. Patients have contraindications for benzodiazepines, opioids, propofol or lidocaine.

6. Patients have benzodiazepines, opioids, propofol, lidocaine suspected narcotic drug abuse history and pain drug or sedative abuse.

7. Patients have history of drug use and/or alcoholism within 2 years before the start of the period. Alcoholism means drinking more than 2 units of alcohol on average per day (1 unit = 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine)