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Efficacy and safety of different doses of remazolam combined with afentanil in painless gastroscopy in elderly patients: a prospective, single-center, randomized, controlled clinical trial

Efficacy and safety of different doses of remazolam combined with afentanil in painless gastroscopy in elderly patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085695
Enrollment
Unknown
Registered
2024-06-17
Start date
2024-06-17
Completion date
Unknown
Last updated
2024-07-08

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 PA propofol2mg/Kg:No drug was given before induction of anesthesia, and 5ug/kg of alfentanil was slowly injected during induction of anesthesia, followed by a slow injection of the correspondin
group RA1 remimazolam 0.15mg/Kg :No drug was given before induction of anesthesia, and 5ug/kg of alfentanil was slowly injected during induction of anesthesia, followed by a slow injection of the cor
group RA2 remimazolam 0.2mg/Kg :No drug was given before induction of anesthesia, and 5ug/kg of alfentanil was slowly injected during induction of anesthesia, followed by a slow injection of the corr
group RA3 remimazolam 0.25mg/Kg :No drug was given before induction of anesthesia, and 5ug/kg of alfentanil was slowly injected during induction of anesthesia, followed by a slow injection of the cor

Sponsors

Central Hospital Affiliated To Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 60 - 80 years; (2) 18kg/m2 <= BMI <= 28kg/m2; (3) ASA (American Society of anesthesiologists) grade II ~ III elderly patients undergoing painless gastroscopy ; (4) Before the trial, the nature, significance, possible benefits, possible inconvenience and potential danger of the trial should be understood in detail, and the research procedure should be understood and the informed consent should be signed voluntarily.

Exclusion criteria

Exclusion criteria: (1)Allergic or contraindicated to benzodiazepines, opioids, propofol and its components; (2) Severe liver and kidney dysfunction (such as elevated serum transaminases>=2.5 times the upper limit of normal values, and blood creatinine levels>=176.8 umol/L); (3)Severe dehydration and severe malnutrition; (4) Severe cardiopulmonary dysfunction (such as heart failure or chronic obstructive pulmonary disease); (5) Patients with neurological or psychiatric diseases or communication disorders before operation; (6)Long term use of opioid drugs or alcoholics; (7)Need trachea intubation general anesthesia; (8)Individuals with severe hearing, vision, intellectual disabilities, and mental illnesses; (9)Patients who refuse to continue with the trial for any reason.

Design outcomes

Primary

MeasureTime frame
Success rate of first dose sedation;

Secondary

MeasureTime frame
Repeated Administration Rate; Anesthesia induction time; Incidence of overall adverse events;Anesthesia awakening time;Patient Satisfaction;

Countries

China

Contacts

Public ContactHuang Haizhen

Central Hospital Affiliated To Shandong First Medical University

huanghaizhen0530@163.com+86 151 6900 5589

Outcome results

None listed

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