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A randomized, controlled, single-blind clinical study on the success rate of remazolam tosylate for injection combined with butorphanol tartrate for sedation in gastrointestinal endoscopy

A randomized, controlled, single-blind clinical study on the success rate of remazolam tosylate for injection combined with butorphanol tartrate for sedation in gastrointestinal endoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042687
Enrollment
Unknown
Registered
2021-01-26
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

diagnosis and treatment of gastrointestinal endoscopy

Interventions

1:remazolam tosylate
2:remazolam tosylate

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18-60 years, regardless of sex. 2)Patients who receive routine gastrointestinal endoscopy. 3) ASA score is I, II or III. 4) 18kg/m2< BMI < 30kg/m2. 5) The operation time of gastrointestinal endoscopy is expected to be no longer than that of 30min. 6) 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) 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). 5) The systolic blood pressure of sitting position during the screening period is less than 90 mmHg. 6) Pregnant or lactating women. 7) Allergic or taboo to benzodiazepines, opioids, lidocaine and their drug components. 8)The liver function the renal function is abnormal. 9) Participated in clinical trials of remazolam tosylate or other drugs as subjects in the past 3 months. 10) The researchers do not think it is appropriate for patients to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;Sedation induction time ;

Secondary

MeasureTime frame
recovery of Neuro psychiatric function;Sedation and awakening time;Incidence of hypotension;Incidence of respiratory depression during sedation;Incidence of sedative hypotension requiring treatment;Satisfaction score;Departure time;

Countries

China

Contacts

Public ContactWen Ouyang

The Third Xiangya Hospital of Central South University

Ouyangwen133@sina.com.cn+86 139 7493 4441

Outcome results

None listed

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