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Clinical study of remimazolam tosilate for injection for gastroscopic sedation: a multicenter, randomized, single-blind clinical trial

Clinical study of remimazolam tosilate for injection for gastroscopic sedation: a multicenter, randomized, single-blind clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038694
Enrollment
Unknown
Registered
2020-09-28
Start date
2020-09-30
Completion date
Unknown
Last updated
2020-12-14

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

Conditions

Gastroscopy

Interventions

1:remimazolam + propofol

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 70 years old; 2) patients who receive routine gastroscopy; 3) ASA score is I or II; 4) 18 kg/m2 < BMI < 30kg/ m2; 5) the operation time of gastroscope is expected to be no longer than that of 30min; 6) No sleep disorder; 7) clearly understand and voluntarily participate in the study, and the informed consent form shall be signed by him.

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) patients who are going to undergo endotracheal intubation; 3) patients with respiratory tract management difficulties (modified Mahalanobis score as IV); 4) anemia or thrombocytopenia, Hb =2.5 ULN,TBIL >=1.5 ULN; 6) the renal function is abnormal and the serum creatinine is higher than the upper limit of the normal value; 7) there is a history of drug use and / or alcohol abuse in the 2 years before the start of the screening period, that is, drinking more than 2 units of alcohol per day on average; (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine). 8) hypertensive patients whose blood pressure was not satisfactorily controlled by antihypertensive drugs (sitting systolic blood pressure >=160mmHg, and / or screening diastolic blood pressure >=100mmHg); 9) the systolic blood pressure of sitting position during the screening period is less than 90 mmHg; 10) pregnant or lactating women; 11) allergic or taboo to benzodiazepines, opioids, propofol, lidocaine and their drug components; 12) participated in clinical trials of other drugs as subjects in the past 3 months; 13) the researchers do not think it is appropriate for patients to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;Effect on sleep status;Gastroscopy physician's satisfaction with the effect of anesthesia;Body movement score;

Secondary

MeasureTime frame
Sedation induction time;Sedation and awakening time;Incidence of hypotension;Incidence of respiratory depression during sedation;

Countries

China

Contacts

Public ContactYonghao Yu

Department of Anesthesiology, General Hospital of Tianjin Medical University

yuyonghao@126.com+86 13920590099

Outcome results

None listed

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