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Sedation effects of remimazolam besylate in frail elderly patients undergoing gastrointestinal endoscopy

Sedation effects of remimazolam besylate in frail elderly patients undergoing gastrointestinal endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095097
Enrollment
Unknown
Registered
2025-01-01
Start date
2025-01-01
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

Depression of respiration, Hypoxia

Interventions

R Group:Remimazolam besylate for sedation
EP Group:Propofol combined with etomidate for sedation

Sponsors

Dazhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Age> 65 years old, gender is not limited; (2) Clinical frailty scale (CFS) score>=5 points; (3) undergo digestive endoscopy for diagnosis and treatment; (4) American Society of Anesthesiologists (ASA) class II or III; (5) Understand and voluntarily participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients undergoing complex endoscopic techniques for diagnosis or treatment; (2) Patients with severe respiratory pathologies (obstructive sleep apnea syndrome, acute respiratory tract infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, oxygen saturation <90% in the inhaled state before examination, etc.) (3) Patients with hemodynamic instability (preoperative visit blood pressure = 180/110 mm Hg or systolic blood pressure <90mm Hg) (4) Those who are allergic to or contraindicated to benzodiazepines, opioids, propofol and etomidate; (5) Patients who were judged to have difficulties in airway management (modified Marhalanobis score grade IV.); (6) Those who have participated in clinical trials of other drugs in the past 3 months; (7) Other conditions that the investigator considers inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia;Depression of respiration;

Countries

China

Contacts

Public ContactLiang Wang

Dazhou Central Hospital

zzxxmmer@163.com+86 818 2386606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026