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Study on the effectiveness and safety of sufentanil combined with remazolam in painless colorectal endoscopy

Study on the effectiveness and safety of sufentanil combined with remazolam in painless colorectal endoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040398
Enrollment
Unknown
Registered
2020-11-28
Start date
2020-11-28
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

digestive tract disease

Interventions

Group 2:propofol
Group 1:remazolam

Sponsors

The Central Hospital of Enshi Tujia and Miao Autonomous Prefesture
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old; 2. Patients undergoing elective painless gastrointestinal endoscopy; 3. ASA I/II; 4. No serious cardiovascular and cerebrovascular diseases, normal liver and kidney function, no history of anesthetic allergy and other special medical conditions. Patients with any of the following exclusion criteria cannot be included in this study; 5. Patients or their family members have a full understanding of the purpose and significance of this trial, volunteer to participate in this clinical trial, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. The patient's physical condition is difficult to evaluate (e.g. severe central nervous system surgery or intracranial surgery); 2. Diabetics with unsatisfactory blood sugar control (11.1mmol/L >=during screening period ); 3. A history of myocardial infarction and unstable angina within 6 months of the screening period; 4. Patients with titration (heart rate 1.5 ULN, APTT >1.5 ULN), hemorrhage tendency (e.g. active peptic ulcers) or receiving thrombolytic or anticoagulant therapy; 8. Abnormal liver function, ALT and/or AST> 1.5 ULN; 9. Abnormal renal function, blood creatinine (Cr) and/or urea nitrogen (BUN) >1.5 ULN; 10. Allergic to the ingredients or components of the drug under test; 11. Pregnant or lactating; 12. Participate in clinical trials of other drugs within 3; 13. Patients with severe muscle weakness, schizophrenia, and severe depression; 14. Patients who are allergic to benzodiazepines.

Design outcomes

Primary

MeasureTime frame
blood pressure;Oxygen saturation;Chung’s score;

Secondary

MeasureTime frame
MOAA/S;Narcotrend;Intleter tolerance score;Anaesthetic wakes up;

Countries

China

Contacts

Public ContactZhu Xianlin

The central hospital of Enshi tujia and miao autonomous prefesture

343205560@qq.com+86 15027224426

Outcome results

None listed

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