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Efficacy and safety of remimazolam tosilate for sedation for gastrointestinal endoscopy in elderly patients: a prospective, randomized, single-blind clinical trial

Efficacy and safety of remimazolam tosilate for sedation for gastrointestinal endoscopy in elderly patients: a prospective, randomized, single-blind clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039334
Enrollment
Unknown
Registered
2020-10-23
Start date
2020-10-15
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

gastrointestinal disease and anesthesia in elderly patients

Interventions

Group 1:Remimazolam Tosilate
Group 2:Propofol

Sponsors

Anesthesiology Dept. The Eighth Afliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 65 and 80 years patients regardless of sex who receive routine gastroscopy; 2. ASA class for I-III; 3. BMI 18kg/m^2-30kg/m^2; 4. Planing to receive gastrointestinal endoscopy From October 2020 to October 2021; 5. The patient or family member fully understood the purpose and significance of this experiment, volunteered to participate in this clinical trial, and signed informed consent.

Exclusion criteria

Exclusion criteria: Patients with any of the following items cannot be enrolled in this study: 1.Complex endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, transoral endoscopic myotomy, etc.). 2.The management of airways were judged to be difficult (Mallampati score of 3) and required trachea cannula. 3.Anemia,thrombocytopenia, abnormal liver function and abnormal renal function, or had a sitting systolic blood pressures of <= 90 mmHg, or had hypertension that was not satisfactorily controlled using antihypertensive drugs. 4.Drug abuse and/or alcoholism within 2 years. 5.Sensitivity to benzodiazepines, opioids, propofol, lidocaine or a contraindication to receiving these medications. 6.Participating any clinical trials of other drugs within 3 months before study initiation. 7.ASA class iv/v, a history of myocardial infarction within 6 months, severe conduction block, malignant arrhythmia, asthma persistence, severe lung infection, allergic constitution, neuromuscular disease, epilepsy history, etc.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Time to adequate sedation;Sedation recovery time;Incidence of hypotension;The incidence of treatment-related hypotension;the incidence of respiratory depression;the percentage of patients in each group who were ready for discharge within 30min of procedure end time;

Countries

China

Contacts

Public ContactCongcai Ren

The Eighth Afliated Hospital of Sun Yat-Sen University

693178372@qq.com+86 13688804466

Outcome results

None listed

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