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Clinical study of remimazolam tosylate for injection and high flow nasal cannular insufflation in gastroscopy diagnosis and treatment

Clinical study of remimazolam tosylate for injection and high flow nasal cannular insufflation in gastroscopy diagnosis and treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041759
Enrollment
Unknown
Registered
2021-01-04
Start date
2021-01-11
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

Painless Gastroscopy

Interventions

experimental group 1:remimazolam tosylate 0.2mg/kg
experimental group 2: remimazolam tosylate 0.3mg/kg
experimental group 3:remimazolam tosylate 0.4mg/kg
control group 1:Propofol medium and long chain fat emulsion
experimental group 4:high flow nasal cannular insufflation
control group 2:Ear hanging nasal catheter for oxygen inhalation

Sponsors

Jianhong Sun
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Subjects of any age and gender; 2. Patients receiving routine gastroscopy diagnosis and treatment; 3. Subjects with ASA grade I or II; 4. Subjects with 18 kg / m2 < BMI < 30 kg / m2; 5. Subjects whose gastroscope operation time is expected to be less than 15 minutes; 6. The subjects who clearly understand and voluntarily participate in the study shall sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who need complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic myotomy, etc.); 2. Patients to be intubated; 3. Patients with respiratory tract management difficulties (modified Mahalanobis grade IV); 4. Patients with hypertension whose blood pressure was not controlled satisfactorily by antihypertensive drugs (sitting systolic blood pressure >= 160 mmHg, and / or diastolic blood pressure >= 100 mmHg); 5. Patients with sitting systolic blood pressure <= 90 mmHg; 6. Pregnant or lactating women; 7. Patients who are allergic or contraindicated to benzodiazepines, propofol, Dyclonine and its components; 8. Patients who are considered unsuitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Hemodynamic inde;????;Sedation success rate;

Secondary

MeasureTime frame
Depth of anesthesia;complication;Wake up quality;

Countries

China

Contacts

Public ContactJianhong Sun

Affiliated Hospital of Yangzhou University

jianhongsun@163.com+86 13605277966

Outcome results

None listed

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