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Application of Remimazolam Tosilate in General Anesthesia During the Perioperative Period: An Exploratory Double-Blind Randomized Controlled Trial

Application of Remimazolam Tosilate in General Anesthesia During the Perioperative Period: An Exploratory Double-Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125920
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

None listed

Interventions

Tobramycin Remimazolam Group (Experimental Group):Induction dose 12mg/kg/h Maintenance method Continuous intravenous infusion (0.6-1.0mg/kg/h)
Propofol group (control group):Induction dose TCI 4 ug/ml Maintenance mode Target concentration 2.5-4.0 µg/ml

Sponsors

The First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 65–80 years (inclusive of 65 years), undergoing elective surgery under general anesthesia, excluding cardiac and neurosurgical procedures. 2. American Society hesiologists (ASA) physical status classification II–III. 3. Anticipated anesthesia duration of not less than 60 minutes and not exceeding 120minutes. 4. Body Mass Index (BMI) of 18.5–28 kg/m^². 5. Full understanding of this trial and provision of written infor

Exclusion criteria

Exclusion criteria: 1. Allergy to anesthetic drugs specified in the protocol. 2. Preoperative cognitive impairment, or the presence of hearing, language communication, motor intellectual disabilities. 3. Severe hepatic or renal insufficiency, combined with severe cardiovascular or pulmonary disease. 4. Long-term use of analgesic drpsychotropic medications. 5. History of psychiatric or neurological disorders, such as depression, epilepsy, or cerebral infarction. 6. History of craniocerebrargery or delirium. 7. Alcohol abuse within the past 3 months (defined as an average daily alcohol intake >2 units, where 1 unit =360 mL beer, 45 mL of 40% alcohol liquor, or 150 mL wine). 8. Undergone other surgeries under general anesthesia within the pst 3 months. 9. Poor adhesion or failure of disposable electroencephalogram (EEG) sensors, severely compromising EEG monitoring quality. 10. Other conditions dinvestigator as unsuitable for continuing participation in this trial.

Design outcomes

Primary

MeasureTime frame
SSD incidence rate;

Secondary

MeasureTime frame
BSR;SEF95;Alpha/Beta power ratio;Incidence of intraoperative hypotension/bradycardia;PONV;injection pain;LOC duration;QoR-15 recovery quality score on postoperative day 1;Duration of Stay in the Post-Anesthesia Care Unit;Postoperative Visual Analogue Scale Score;Intraoperative awareness;RASS score after extubation;duration of extubation;recovery time;

Countries

China

Contacts

Public ContactKun Wang

The First Affiliated Hospital of Harbin Medical University

hydwangkun@sina.com+86 139 3601 3651

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026