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Comparison of safety and efficacy of remifentanil besylate and propofol in painless gastroscopy for elderly patients

Comparison of safety and efficacy of remifentanil besylate and propofol in painless gastroscopy for elderly patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110081
Enrollment
Unknown
Registered
2025-09-30
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Painless Gastrointestinal Endoscopy

Interventions

Trails I: Group L (65-70):Sufentanil 5µg + Remimazolam Besylate 0.15 mg/kg (1 mg/mL)
Trails I: Group H (>70):Sufentanil 5µg + Remimazolam Besylate 0.1 mg/kg (1 mg/mL)
Trial II: Group R:Sufentanil 0.05µg/kg + Remimazolam Besylate 0.15mg/kg
Trial II: Group P:Sufentanil 0.05µg/kg + Propofol 1mg/kg

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 65-75 years, regardless of gender; 2.BMI 18.5-30 kg/m^2; 3.ASA physical status Class I-II; 4.STOP-Bang score <5; 5.Patients deemed suitable for painless gastroscopy, colonoscopy, or combined gastrointestinal endoscopy after anesthesia assessment clinic evaluation; 6.Voluntarily participated and provided signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Chronic pain patients on long-term analgesics, psychoactive medications (including opioids, NSAIDs, sedatives, antidepressants), or alcohol abusers. 2.Preoperative clinically significant elevation of liver/kidney function markers (ALT, AST, BUN, Cr); 3.Pre-existing severe central nervous system disorders or major psychiatric conditions; 4.Individuals with opioid addiction or dependence; 5. Participation in other clinical trials within 4 weeks prior; 6.Body weight is 15% below or above the standard weight

Design outcomes

Primary

MeasureTime frame
the Median Effective Dose of Remimazolam Besylate for Successful Gastroscope Insertion in Elderly Patients of Different Age Groups;Incidence of Low oxygen (Trial II);

Secondary

MeasureTime frame
Incidence of Hypoxemia;Vital Signs;Anesthesia Recovery Time Metrics;Anesthesia-Related Medications;Adverse Reactions;Success rate of initial mirror placement;Incidence of body movement events;Subclinical respiratory depression incidence rate;vital signs;Anesthesia recovery time;

Countries

China

Contacts

Public ContactLixin An

Beijing Friendship Hospital, Capital Medical University

anlixin8120@163.com+86 138 1024 8120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 13, 2026