Skip to content

Effect of continuous infusion of remazolam with different doses on brain protection in patients with craniocerebral tumor resection

Effect of continuous infusion of remazolam with different doses on brain protection in patients with craniocerebral tumor resection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100491
Enrollment
Unknown
Registered
2025-04-10
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Intracranial tumor operation

Interventions

Propofol (Contral):Patients in group C were given propofol 2-2.5mg/kg during anesthesia induction and IV propofol 4-10 mg/kg /h during anesthesia maintenance.
Remazolam Group Low Dose (R1):According to the instructions for use, remazolam was given 0.3 mg/kg during anesthesia induction and 1.0mg /kg/h intravenously during anesthesia maintenance.
Remazolam Medium Dose (R2):According to the instructions for use, remazolam was given 0.3 mg/kg during anesthesia induction and 2.0mg /kg/h intravenously during anesthesia maintenance.
Remazolam Group High Dose (R3):According to the instructions, remazolam was given 0.3 mg/kg during anesthesia induction and 3.0mg /kg/h intravenously during anesthesia maintenance.

Sponsors

Guiyang Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Study intends to include healthy patients aged 18-60 years old; 2. Bmi 18-28kg/m^2; 3.ASA grade I-III; 4. No abnormality in hearing and memory function; 5. No history of long-term use of sedative drugs.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to general anesthesia; 2.Patients who have used narcotic analgesics within 24 hours or used narcotic drugs within 5 days, long-term (continuous or intermittent) use of benzodiazepines sleeping pills, opioid analgesics; 3. Have a history of serious cardiovascular disease (such as myocardial ischemia, heart failure and arrhythmia); Patients with angina pectoris due to insufficient coronary blood supply to the heart (unstable angina), or who have had a myocardial infarction within the last 6 months; 4. Patients with hypertension whose blood pressure was not satisfactorily controlled by antihypertensive medication (recumbent systolic blood pressure =180 mmHg, and/or diastolic blood pressure =110 mmHg during the screening period); 5. Pregnant or lactating women; 6. Liver and kidney insufficiency; 7. Patients with mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.), drug history and cognitive dysfunction; 8. Participated in drug clinical trials as a subject within the last 3 months; 9. Patients who are deemed unfit by the investigator to participate in this trial; 10. Patients whose subjects refuse to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure and Heart rate;Onset time of administration;Patient recovery time;Inflammatory markers (NSE, S100ß, GFAP, IL-6, CRP, TNF-a);

Secondary

MeasureTime frame
Incidence of adverse reactions;Evaluation of intraoperative awareness;

Countries

China

Contacts

Public ContactJingjiew Wang

Guiyang Second People's Hospital

690229853@qq.com+86 185 8581 6051

Outcome results

None listed

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