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Safety and effectiveness of remimazolam tosylate in painless gastroscopy/colonoscopy diagnosis and treatment: a randomized controlled trial

Safety and effectiveness of remimazolam tosylate in painless gastroscopy/colonoscopy diagnosis and treatment: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035813
Enrollment
Unknown
Registered
2020-08-17
Start date
2020-08-15
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Colonoscopy and gastroscopy

Interventions

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 18 <= age <= 60 years old, no gender limit; 2) Patients receiving routine colonoscopy and/or gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2 <= BMI <= 30kg/m2; 5) It is estimated that the colonoscopy and/or gastroscopy operation time will not exceed 30 minutes; 6) Clearly understand and voluntarily participate in the research, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Complicated endoscopic diagnosis and treatment techniques are required (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic muscle dissection, etc.); 2) Patients who intend to undergo tracheal intubation; 3) Patients who are judged to be difficult to manage the respiratory tract (modified Markov score is IV); 4) Anemia or thrombocytopenia, Hb = 2.5 * ULN, TBIL >= 1.5 * ULN; 6) Abnormal renal function, blood creatinine is greater than the upper limit of normal; 7) There is a history of drug abuse and/or alcohol abuse within 2 years before the beginning of the screening period, which means drinking more than 2 units of alcohol per day on average (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol content or 150 mL wine); 8) Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs (sitting systolic blood pressure >= 160 mmHg in the screening period, and/or diastolic blood pressure >= 100 mmHg in the screening period); 9) Sitting systolic blood pressure <= 90 mmHg during the screening period; 10) Women who are pregnant or breastfeeding; 11) Allergic or contraindicated 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 investigator believes that it is inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
MOAA/S score;

Secondary

MeasureTime frame
Blood pressure;Breath rate;Heart rate;Blood oxygen saturation;Recovery time;

Countries

China

Contacts

Public ContactLan-Ren Chen

Anhui Provincial Cancer Hospital

chinachenlanren@126.com+86 18963790383

Outcome results

None listed

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