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Remazolam toluenesulfonate combined with esketamine for the efficacy and safety of analgesic sedation in ICU patients on mechanical ventilation: a single arm trial clinical study protocol

Remazolam toluenesulfonate combined with esketamine for the efficacy and safety of analgesic sedation in ICU patients on mechanical ventilation: a single arm trial clinical study protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053106
Enrollment
Unknown
Registered
2021-11-10
Start date
2022-10-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

Analgesia and sedation in ICU patients with mechanical ventilation

Interventions

Experimental group:Remazolam toluenesulfonic combined with esketamine

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Aged > 18 years; 2.Mechanically ventilated patients admitted to ICU (72 hours >= mechanical ventilation time >= 24 hours); 3.Analgesia and sedation treatment is needed because of the condition; 4.Sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Allergic or contraindicated to benzodiazepines, propofol and other research medicine and components; 2.Patients with a history of opioid abuse; 3.Pregnancy or lactation; 4.Patients with hemodynamic instability, often accompanied by systolic blood pressure less than 90 mmHg; 5.Suffer from mental illness, history of drug use and/or alcohol abuse; 6.Patients with severe central nervous system diseases (such as acute stroke, uncontrolled epilepsy, severe dementia); 7.Patients with intracranial hypertension, acute respiratory distress syndrome, prone ventilation, and other patients who need deep sedation as assessed by the investigator; 8.Severe ventricular dysfunction or II-III °atrioventricular block; HR < 55/min; 9.Acute coronary syndrome (such as unstable angina pectoris, acute myocardial infarction); 10.Researchers think it is not appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Time to keep the target sedation;

Secondary

MeasureTime frame
The total amount of sedative and analgesic medicine used to reach the target sedative level for the first time;Total time of mechanical ventilation;Wake up time;Lenth of Hospital Stay;

Countries

China

Contacts

Public ContactChunting Wang

Shandong Provincial Hospital Affiliated to Shandong First Medical University

wcteicu@126.com+8615805311555

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026