Comparison of sedative drugs used during gastrointestinal endoscopy in elderly patients

Comparison of propofol and remimazolam as sedatives for therapeutic gastrointestinal endoscopic procedure in elderly patients: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011565

Enrollment

Registered

2026-02-02

Start date

2026-02-08

Completion date

Unknown

Last updated

2026-02-09

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

Conditions

None listed

Interventions

Drug : This study involves elderly patients undergoing therapeutic gastrointestinal endoscopic procedures, in whom moderate-to-deep sedation is maintained under monitored anesthesia care using either

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Elderly patients scheduled to undergo therapeutic gastrointestinal endoscopic procedures under monitored anesthesia care (MAC) - Age between 60 and 85 years - American Society of Anesthesiologists (ASA) physical status classification I–III - Ability to understand the study procedures and provide written informed consent

Exclusion criteria

Exclusion criteria: - American Society of Anesthesiologists (ASA) physical status classification IV or higher - Body mass index (BMI) 30 kg/m² - Anticipated difficult airway (Modified Mallampati classification III or IV) - Presence of acute respiratory infection, uncontrolled asthma exacerbation, or uncontrolled hypertension - History of drug abuse and/or alcohol dependence within 2 years prior to screening - Significant neuropsychiatric disorders, including inability to communicate, dementia, schizophrenia, or major depressive disorder - Known allergy or contraindication to benzodiazepines, opioids, or propofol - Any other condition deemed inappropriate for study participation by the investigator

Design outcomes

Primary

Measure	Time frame
Time to full recovery (time to achieve a modified Aldrete score = 9)	—

Secondary

Measure	Time frame
Occurrence of oxygen reserve index (ORI) decrease to <50% of baseline;Time to reach the lowest oxygen reserve index (ORI) during the procedure;Occurrence of oxygen desaturation (SpO2 <94%) during the procedure;Requirement for airway interventions (e.g., jaw thrust, airway adjuncts, assisted ventilation);Occurrence of hypotension or bradycardia during the procedure;Occurrence of patient body movements during the procedure;Consumption of adjunct analgesics (fentanyl and ketamine) ;Length of stay in the recovery room;Adverse events in the recovery room;Procedural recall;Patient satisfaction score	—

Measure

Time frame

Occurrence of oxygen reserve index (ORI) decrease to <50% of baseline;Time to reach the lowest oxygen reserve index (ORI) during the procedure;Occurrence of oxygen desaturation (SpO2 <94%) during the procedure;Requirement for airway interventions (e.g., jaw thrust, airway adjuncts, assisted ventilation);Occurrence of hypotension or bradycardia during the procedure;Occurrence of patient body movements during the procedure;Consumption of adjunct analgesics (fentanyl and ketamine) ;Length of stay in the recovery room;Adverse events in the recovery room;Procedural recall;Patient satisfaction score

—

Countries

Korea, Republic of

Contacts

Public ContactHyun Kang

Chung-Ang University

roman00@naver.com+82-2-6299-2579

Outcome results