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Clinical study on sedative efficacy and safety of different doses of cyclopropofol in gastroscopic diagnosis and treatment of elderly patients

Clinical study on sedative efficacy and safety of different doses of cyclopropofol in gastroscopic diagnosis and treatment of elderly patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044875
Enrollment
Unknown
Registered
2021-03-31
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

Gastroscopy diagnosis and treatment

Interventions

Test group 1:Intravenous injection of Ciprofol 0.2mg/kg
Test group 2:Intravenous injection of Ciprofol 0.4mg/kg
Control group:Intravenous injection of propofol 1mg/kg

Sponsors

Affiliated Cancer Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 60 to 80 years, regardless of gender; 2.Patients who received routine gastroscopy; 3.ASA score was grade I or grade II; 4.18 kg/m^2 < BMI < 30kg / m^2; 5.They clearly understood and volunteered to participate in the study, and the informed consent form was signed by them.

Exclusion criteria

Exclusion criteria: 1.Patients undergoing endotracheal intubation (including laryngeal mask); 2.Acute heart failure; unstable angina pectoris; myocardial infarction within 6 months before screening; resting ECG heart rate = 160mmHg or = 100mmHg). 9.Patients are allergic or contraindicated to benzodiazepines, opioids, propofol and their drug components; 10.Have participated in clinical trials of other drugs as subjects in the past 3 months; 11.The researchers believe that patients should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Sedation induction time;Calm recovery time;Discharge time;Sedative hypotension rate;Incidence of respiratory depression during sedation;Satisfaction scores of anesthesiologists, endoscopists and patients;Incidence of abnormal heart rate events;Incidence of blood pressure fluctuation events;Incidence of other adverse events during entering the examination room-leaving the recovery room;

Countries

China

Contacts

Public ContactYi Qianglin

Affiliated Cancer Hospital of Guizhou Medical University

691206869@qq.com+86 13595056784

Outcome results

None listed

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