Comparison of remimazolam versus midazolam for procedural sedation during percutaneous endoscopic gastrostomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009897

Enrollment

148

Registered

2024-11-04

Start date

2024-11-19

Completion date

Unknown

Last updated

2024-11-14

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

Conditions

None listed

Interventions

Drug : Among patients undergoing percutaneous endoscopic gastrostomy by applying patient monitoring under anesthesia (MAC), a total of 156 adult volunteers (American Department of Anesthesiology physi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20-80 years old 2) American Society of Anesthesiologists Physical Grade (ASA) Grade 1-3 3) Patients scheduled for percutaneous endoscopic gastrostomy under anesthesia management (MAC) (patients indicated for percutaneous endoscopic gastrostomy) 4) Patients who agreed to the consent form

Exclusion criteria

Exclusion criteria: 1) Patients who refuse consent 2) Under 20 years old, over 80 years old 3) Pregnancy 4) History of allergy to midazolam, opioid, or remimazolam 5) Serious psychiatric problems 6) History of alcohol and drug addiction 7) Patients with ASA grade 4 or higher 8) Patients who cannot understand the contents of the consent form due to severe cognitive impairment

Design outcomes

Primary

Measure	Time frame
1. Onset time and recovery time of the drug 2. Comparison of side effects estimated to be caused by drugs during the procedure (drug safety) a. Bradycardia, hypotension, hypoventilation or apnea, cough, hypoxia, vomiting, post-procedural nausea, respiratory failure.	—

Secondary

Measure	Time frame
1. Degree and appropriateness of sedation intensity during the procedure a. MOAA/S score (Modified Observers Assessment alertness/sedation) b. Survey of doctors’ satisfaction with sedation and procedures	—

Countries

Korea, Republic of

Contacts

Public ContactJin Hwa Park

Hanyang University Seoul Hospital

pjh6718@hanmail.net+82-2-2290-8303

Outcome results