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The application effect of remimazolam besylate for injection on upper gastrointestinal mucosal stripping surgery in elderly patients

The application effect of remimazolam besylate for injection on upper gastrointestinal mucosal stripping surgery in elderly patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101425
Enrollment
Unknown
Registered
2025-04-24
Start date
2024-03-20
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Upper gastrointestinal mucosal dissection

Interventions

Propofol group (Group P) : 2mg/kg of propofol was induced by anesthesia, and 4-10mg/kg/h of propofol was maintained by anesthesia.:During endotracheal intubation and surgery, additional drugs should b
Remazolam group (R group) : Remazolam 0.4mg/kg was induced by anesthesia and remazolam 0.5-1.5mg/kg/h was maintained by anesthesia:During endotracheal intubation and surgery, additional drugs should b

Sponsors

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients of both sexes had to meet all of the following inclusion criteria: 1) age <= 65 years <= 85 years; 2) patients undergoing elective upper gastrointestinal mucosal dissection; 3)ASA grade I, II, and III; 4)18 kg/m^2 < BMI < 30kg/m^2; 5) Informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients with any of the following could not be enrolled. 1) patients with mental disorders or nervous system diseases; 2) patients who take psychotropic drugs such as diazepam and anti-anxiety drugs, or abuse alcohol or drugs; 3) patients with language communication, vision or hearing impairment; 4) patients with airway management difficulties (modified Mahalanobis score grade IV); 5) patients whose blood pressure was not well controlled by antihypertensive drugs (sitting systolic blood pressure ?160mmHg during screening and/or diastolic blood pressure ?100mmHg during screening); 6) systolic blood pressure 2, basic SpO2<92%); 9) severe liver and renal impairment; 10) Allergic or contraindicated to benzodiazepines, propofol, and their drug components; 11) have participated in a clinical trial of remimazolam or other drugs as a subject within the past 3 months; 12) patients who were deemed by the investigators to be ineligible to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Eye opening time;

Secondary

MeasureTime frame
Upon eye opening at the end of surgery, the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was assessed.;Timing of tracheal extubation following anesthesia cessation and sedation-agitation score during extubation;Ramsay Sedation Score at 5 minutes post-extubation ;surgical duration, and hospitalization days;Incidence rate of adverse reactions following tracheal extubation;Patient and surgeon satisfaction;

Countries

China

Contacts

Public ContactZhou Suli

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial Hospital)

9714689@qq.com+86 173 1495 9520

Outcome results

None listed

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