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Efficacy and Safety of Remimazolam Tosilate Plus Lidocaine in Elderly Patients Undergoing Painless Gastroscopy

Efficacy and Safety of Remimazolam Tosilate Plus Lidocaine in Elderly Patients Undergoing Painless Gastroscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104423
Enrollment
Unknown
Registered
2025-06-17
Start date
2025-06-25
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Painless gastroscopy for elderly patients

Interventions

Group RL1:Remimazolam tosilate + lidocaine (1.0 mg/kg)
Group RL2:Remimazolam tosilate + lidocaine (0.5 mg/kg)
Group RN:Remimazolam tosilate + normal saline
Group R:Optimal dose of remimazolam tosilate + 0.5 mg/kg lidocaine
Group B:Propofol 1.5 mg/kg + lidocaine 0.5 mg/kg

Sponsors

Ya 'an People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1Age>= 65 years; 2. BMI 18–28 kg/m^2; 3.ASA physical status class I~II.

Exclusion criteria

Exclusion criteria: 1. Preoperative systolic blood pressure>= 180 mmHg or diastolic blood pressure>= 110 mmHg or heart rate>= 110 beats/min; 2 .History of hypersensitivity to the trial drugs; 3.History of neurological disorders or inability to communicate normally; 4. Long-term use of sedative/analgesic medications; 5 .Patient or family members declined to participate.

Design outcomes

Primary

MeasureTime frame
Effective Dose 50%(ED50) and Effective Dose 95%(ED95) of remimazolam tosilate;Number of patients with MOAA/S score<=2 after drug administration;

Secondary

MeasureTime frame
Number of patients with Modified Observer's Assessment of Alertness/Sedation Scale(MOAA/S score) >2 after administration;Blood pressure;Heart rate;Injection pain;Malignant, vomiting;Oxygen saturation;Inspection duration;Duration of wakefulness;Fatigue degree score;Patient and doctor satisfaction scores;

Countries

China

Contacts

Public ContactYang Zhuo Xuan

Ya 'an People's Hospital

yzxyzyx@163.com+86 158 0814 6502

Outcome results

None listed

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