NCT05103696

A Comparative Study of Rimazolam and Propofol Combined With Etomidate in Gastroenteroscopy in Elderly Patients

Safety and Efficacy of Remazolam in Gastroenteroscopy in Elderly Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Studies have shown that etomidate combined with propofol in gastroscopy has high safety and lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined with propofol in elderly patients. Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be more suitable for elderly patients. Therefore, this study intends to explore the safety and effectiveness of two sedation schemes in gastroenteroscopy for elderly patients.

Detailed description

Before starting the endoscopy procedures, patients were randomly assigned to either Remimazolam Besylate group or propofol combined with etomidate group. The onset time, recovery time, vital signs, postoperative recovery, cognitive function and adverse events were compared.

Conditions

• Elderly Patients
• Gastrointestinal Endoscopy
• Remimazolam Besylate
• Etomidate Combined With Propofol

Interventions

Type	Name	Description
DRUG	Remimazolam Besylate	Remazolam 7mg for the first time (push time 1min), 2.5mg can be added after 2min according to MOAA/S score, no more than 5 times within 15min
DRUG	etomidate combined with propofol	Etomidate 0.1mg/kg+1% propofol 0.5mg/kg for the first time ,etomidate0.05mg/kg+ 1% propofol 0.25 mg/kg can be added according to MOAA/S score

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-12-01
• Completion: 2023-03-30
• First posted: 2021-11-02
• Last updated: 2023-07-14

Locations

1 site across 1 country: China