Status:
UNKNOWN
Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Conditions:
Endoscopic Ultrasonography-guided Fine Needle Aspiration
Sedation Complication
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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-F...
Detailed Description
Endoscopic ultrasonography-guided fine needle aspiration/biopsy (EUS-FNA/FNB) is an important basis for the diagnosis of lesions in the upper gastrointestinal tract and adjacent organs, and plays an i...
Eligibility Criteria
Inclusion
- Age: ≥18 years old and ≤75 years old
- BMI: 18kg/m\^2\<BMI\<30kg/m\^2;
- Body weight: 40kg\<weight\<120kg
- Patients who intend and qualified to undergo sedated EUS-FNA/FNB.
- Clearly understand, voluntarily participate in the research, and sign the informed consent form.
Exclusion
- Patients who are not suitable for sedated EUS-FNA/FNB for any reason (e.g. cardiovascular disease)
- Patients have abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN;
- Patients have abnormal renal function, urea or blood urea nitrogen≥1.5×ULN, serum creatinine≥1.0 ×ULN
- Those who are allergic to benzodiazepines, opioids, propofol or lidocaine.
- Patients have contraindications for benzodiazepines, opioids, propofol or lidocaine.
- Patients have benzodiazepines, opioids, propofol, lidocaine suspected narcotic drug abuse history and pain drug or sedative abuse.
- 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)
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT05437497
Start Date
August 1 2021
End Date
December 31 2022
Last Update
June 29 2022
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013