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

NCT05437497 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2022-06-29

No results posted yet for this study

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.

Conditions

  • Endoscopic Ultrasonography-guided Fine Needle Aspiration
  • Sedation Complication
  • Remimazolam

Interventions

DRUG

Remimazolam Injection

The experimental group was sedated with remimazolam

DRUG

Propofol Injection

The control group was sedated with propofol

Sponsors & Collaborators

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Xiaoyan Wang, Doctor · The Third Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437497 on ClinicalTrials.gov