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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008128

Enrollment

132

Registered

2023-01-17

Start date

2023-02-22

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. Study drug (Remimazolam) An initial dose of 5 mg is administered intravenously over 1 minute. Depending on the state of sedation, if necessary, 2.5 mg may be administered up to 5 times with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult men and women between the ages of 18 and 60 at the time of obtaining consent 2) Those who are scheduled for a sedative upper endoscopy for diagnostic purposes 3) Those who are expected to perform endoscopy in less than 15 minutes 4) American Society of Anesthesiologists (ASA) Score = 2 5) Those with a BMI of 18.5 kg/m2 or more and less than 30 kg/m2

Exclusion criteria

Exclusion criteria: 1) A person who is suspected of having a pathological condition in the gastrointestinal tract and is likely to need a therapeutic endoscopy 2) Those who have a history of breathing problems during sedation (e.g. chronic obstructive pulmonary disease, respiratory disorders due to cerebrovascular disease and musculoskeletal muscle disease, those with tracheal cannulas, etc.) 3) Those who are judged to have difficulty maintaining the airway (Mallampati Score = 3) 4) Subjects with a sitting systolic blood pressure of 160 mmHg or more or 90 mmHg or less before randomization 5) Patients with uncontrolled hypertension 6) Patients with acute narrow-angle glaucoma 7) Patients with severe hepatic impairment or chronic kidney disease 8) Those with a history of drug abuse or alcohol abuse in the past 1 year 9) Those with hypersensitivity to other benzodiazepine drugs and components of remimazolam (eg, dextran, etc.) 10) Those with hypersensitivity to the components of midazolam 11) Patients with sleep apnea syndrome 12) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 13) Pregnant women, lactating women, or those who have a positive pregnancy test during screening

Design outcomes

Primary

Measure	Time frame
Total procedure time	—

Secondary

Measure	Time frame
recovery time	—

Countries

Korea, Republic of

Contacts

Public ContactTae Jun Kim

Samsung Medical Center

tj23.kim@samsung.com+82-2-3410-3409

Outcome results