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Application of remimazolam tosylate for injection combined with propofol sedation regimen in painless endoscopy

Application of remimazolam tosylate for injection combined with propofol sedation regimen in painless endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060510
Enrollment
Unknown
Registered
2022-06-03
Start date
2022-05-25
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Peptic ulcer

Interventions

Group 1:Remimazolam combined with propofol

Sponsors

Changzhou Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old <= age <= 70 years old; 2. Gender is not limited; 3. Patients undergoing routine gastroenteroscopy and simple diagnosis and treatment 4. ASA I or II; 5. 18kg/m2 < BMI <30kg/m2; 6. Informed consent, voluntarily participated in the trial, and the patients themselves signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient has severe communication impairment due to severe hearing deterioration and other reasons; 2. It is expected that other drugs other than the preoperative preparation plan, sedation plan, and normal saline need to be used during the operation due to various reasons; 3. Women who are pregnant or breastfeeding; 4. The subject has a history of severe motion sickness and severe vertigo; 5. Subjects with difficult airway: Mallampati grade >= grade III, limited neck movement, nail-mind distance < 6cm, etc.; 6. The patient has a history of sleep apnea syndrome; 7. Have a history of drug abuse, drug abuse and alcohol abuse within the previous two years; 8. The patient explicitly refuses to participate in this study; 9. Participated in clinical trials of other drugs or devices within 3 months before the screening period; 10. Patients had a history of surgery under general anesthesia within 1 month before the study or had surgery planned within 1 month.

Design outcomes

Primary

MeasureTime frame
Hemodynamics;

Secondary

MeasureTime frame
Degree of fatigue;Injection pain;Postoperative nausea and vomiting;Wake up time;

Countries

China

Contacts

Public ContactYun Huifang

Changzhou Second People's Hospital

yhfdoctor@163.com+86 13813568778

Outcome results

None listed

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