Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Healthy Clinical Trial

Official title:

A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05836545
• Other study ID #: 2022-08-2391
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Samsung Medical Center
• Contact: Taejun Kim
• Phone: +821051365877
• Email: tj23.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are:

• Superiority of total procedure time in remimazolam compared to midazolam

• The success of sedation time

This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients who agreed for this clinical trials

• Patients who want diagnostic endoscopy under sedation

• The total procedure time which is predicted within 15 minutes

• ASA >=2

• BMI more than 18.5kg/m2, less than 30kg/m2

Exclusion Criteria:

• Patients who have stomach illness

• Patients with respiratory disease

• Mallampati Score>=3

• Systolic BP >160mmHg or <90mmHg

• Refractory Hypertension

• Uncontrolled glaucoma

• Severe liver failure or chronic kidney disease

• Patients with drug abuse or alcohol abuse within 1 year

• Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam)

• Obstructive sleep dyspnea patients

• Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Pregnant, breast feeding patient

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Remimazolam
The patient with remimazolam
• Midazolam
The patient with midazolam

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total procedure time		begin when the drug is give to when the endoscopy is withdrawn
Secondary	The success rate of sedation		Completion of the whole endoscopy procedures, No requirement for an alternative and/or rescue sedative, Administered up to a maximum of five supplemental doses within 15 mnutes after the initial dose