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Randomised controlled study comparing use of Remimazolam Tosilate plus fentanyl versus propofol plus fentanyl for anesthesia in elderly patients undergoing gastrointestinal endoscopy

Randomised controlled study comparing use of Remimazolam Tosilate plus fentanyl versus propofol plus fentanyl for anesthesia in elderly patients undergoing gastrointestinal endoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035824
Enrollment
Unknown
Registered
2020-08-18
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Anesthesia

Interventions

Remimazolam Tosilate:Injection Remimazolam
Diprivan:Injection Diprivan

Sponsors

Department of Anesthesiology, the Third Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Aged 65 to 85 years; (2) The American society of anesthesiologists (ASA) class I ~ II, or ASA class III that basic diseases in internal medicine were under stable control; (3) 18 kg/m2 < Body mass index (BMI) < 30kg /m2; BMI = weight/height squared in kg/m2.

Exclusion criteria

Exclusion criteria: (1) Patients requiring endotracheal intubation; (2) Difficult airway, acute respiratory infection and asthmatic attack stage; (3) Uncontrolled severe hypertension or hypotension (systolic blood pressure >=160 mmHg, diastolic blood pressure >=100 mmHg, systolic blood pressure <= 90 mmHg, diastolic blood pressure <= 60 mmHg, consistent with any one item), severe arrhythmia, and unstable angina; (4) Anemia, Hb < 80g/L; (5) A history of drug abuse and/or alcohol abuse within 2 years prior to the start of the screening period, i.e. an average of more than 2 units of alcohol per day (1 unit =360 mL beer or 45 mL white wine or 150 mL wine with a 40% alcohol content); (6) Acute upper gastrointestinal hemorrhage, acute gastrointestinal perforation, gastrointestinal obstruction accompanied by gastric content retention; (7) A history of mental illness or long-term use of psychotropic drugs or chronic analgesics; (8) Allergic to benzodiazepines, opioids, propofol, lidocaine and their drug components; (9) Patients had taken other test drugs or been involved in other clinical trials within three months prior to the present stud; (10) Endoscopic diagnosis and treatment time is more than 30 minutes; (11) Not suitable for the study, after assessment by the investigators.

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension;Incidence of sedative hypotension requiring treatment;Incidence of respiratory depression;

Countries

china

Contacts

Public ContactYanjuan Huang

Department of Anesthesiology, the Third Affiliated Hospital of Guangxi Medical University

huangyanjuan66@163.com+86 13878825731

Outcome results

None listed

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