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Application of remimazolam besylate in painless gastrointestinal endoscopy in elderly patients

Application of remimazolam besylate in painless gastrointestinal endoscopy in elderly patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054129
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-09
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Gastrointestinal diseases

Interventions

control group:Sufentanil 0.1ug/kg+ propofol 1.5mg/kg
experimental group:Sufentanil 0.1ug/kg+ remimazolam 7mg

Sponsors

Shanghai East Hospital (Affiliated East Hospital of Tongji University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. The age is over 60 years old, and the gender is not limited; 2. Patients receiving routine gastric and colonoscopy examinations; 3. American Society of Anesthesiologists ASA I-III grade; 4. BMI 18.5-30kg/m^2; 5. Informed consent, voluntarily participate in the trial, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are judged to be difficult to manage the respiratory tract (modified Markov score is grade IV); 2. Anemia or thrombocytopenia, Hb=2.5xULN, TBIL>=1.5xULN; 4. Abnormal renal function, serum creatinine is greater than the upper limit of normal; 5. A history of drug and/or alcohol abuse within 2 years prior to the start of the screening period. Alcohol abuse is an average of more than 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol content or 150 mL of wine); 6. Hypertensive patients whose blood pressure is not satisfactorily controlled by antihypertensive drug treatment (sitting systolic blood pressure >=160 mmHg during screening period, and/or diastolic blood pressure >=100 mmHg during screening period); 7. Sitting systolic blood pressure <=90 mmHg during the screening period; 8. Those who are allergic to or have contraindications to benzodiazepines, opioids, propofol, lidocaine and their drug components; 9. Those who have a history of abnormal surgical anesthesia recovery in the past; 10. Subjects deemed unfit for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Awakening time;Drug top-up times;Incidence of injection pain;Incidence of hypotension;Heart rate variability;Incidence of hypoxia;Incidence of respiratory depression;

Countries

China

Contacts

Public ContactWang Yinglin

Shanghai East Hospital (Affiliated East Hospital of Tongji University)

13907553360@163.com+86 13907553360

Outcome results

None listed

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