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A Randomized Controlled Trial Comparing the Effective Dose of Remimazolam Tosylate for Loss of Consciousness During General Anesthesia Induction Between Elderly and Non-elderly Patients

Effect of different ages on effective dose of Remazolam combined with sufentanil during general anesthesia induction in day surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091138
Enrollment
Unknown
Registered
2024-10-22
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

day surgery

Interventions

Non-elderly group 1:0.1ug/kg sufentanil and 0.1mg/kg remimazolam
Non-elderly group 2:0.1ug/kg sufentanil and 0.2mg/kg remimazolam
Non-elderly group 3:0.1ug/kg sufentanil and 0.3mg/kg remimazolam
Non-elderly group 4:0.1ug/kg sufentanil and 0.4mg/kg remimazolam
Elderly group 1:0.1ug/kg sufentanil and 0.1mg/kg remimazolam
Elderly group 2:0.1ug/kg sufentanil and 0.2mg/kg remimazolam
Elderly group 3:0.1ug/kg sufentanil and 0.3mg/kg remimazolam
Elderly group 4:0.1ug/kg sufentanil and 0.4mg/kg remimazolam

Sponsors

The First People's Hospital of Linping District, Hangzhou , Zhejiang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients older than 18 years; 2. American Society of Anesthesiologists(ASA) physical status I-III; 3. Day surgery under general anesthesia; 4. body mass index(BMI) between 18-30kg/m^2. 5.Sign informed consent,accepted the experimental method, volunteered as a subject.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. Allergic to remimazolam or have contraindications to use remimazolam (acute angle closure glaucoma, myasthenia gravis, shock, coma and acute alcoholism); 3. Preoperative disturbance of consciousness or have chronic pain with prolonged use of analgesics, psychotropic drug(Including opiates,NSAIDs, sedative, antidepressant),alcohol abuser; 4. Use of sedatives, antiemetic, antipruritic drugs 24 hours before surgery or monoamine oxidase inhibitors or antidepressants within 15 days before surgery; 5. Any history of abnormal upper airway airway management or respiratory insufficiency or sleep apnea that could cause difficulty breathing; 6. History of liver surgery, renal or liver insufficiency, history of gastrointestinal ulcers or bleeding tendency; 7. Researchers who do not agree to participate in or are participating in other drug trials; 8. Patients with tumors and severe cardiovascular and cerebrovascular diseases were not considered suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
BIS;

Secondary

MeasureTime frame
MOAA/S sedation score;HR,NIBP,SPO2;Ask patients about pain during the injection;Incidence of respiratory depression,Incidence of hypotension,Incidence of bradycardia at induction;adverse reaction(Incidence of buckling,hiccup,bucking,muscular fibrillation);postoperative nausea and vomiting(PONV);

Countries

China

Contacts

Public ContactJunli Zheng

The First People's Hospital of Linping District, Hangzhou , Zhejiang

263806434@qq.com+86 153 9715 2723

Outcome results

None listed

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