Study on awakening time and degree of Remazolam toluenesulfate for injection after continuous sedation in patients with mechanical ventilation in ICU

Study on awakening time and degree of Remazolam toluenesulfate for injection after continuous sedation in patients with mechanical ventilation in ICU - ICU Remazolam resuscitation study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300071553

Enrollment

Unknown

Registered

2023-05-18

Start date

2023-05-18

Completion date

Unknown

Last updated

2023-06-12

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

Conditions

Analgesics-sedatives

Interventions

Experimental group (Remazolam group):Remazolam (0.1-0.2mg/kg.h) + Remifentanil (3-60ug/kg.h)

Control group (midazolam group):Midazolam (0.02-0.10mg/Kg.h) + Remifentanil (3-60ug/kg.h)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) ICU patients admitted to our hospital. (2) Patients with mechanical ventilation through oral tube intubation, whose estimated mechanical ventilation time is more than 12 hours, need continuous sedation and analgesia treatment. (3) Aged 18-80, weight 45-100kg. (4) The consent form shall be signed by the applicant himself or his family members.

Exclusion criteria

Exclusion criteria: (1) Known allergy to remazolam, midazolam, remifentanil. (2) severe stroke, severe encephalitis and other central nervous system diseases. (3) Patients with a history of mental illness, schizophrenia or severe depression. (4) Severe hypotension. (5) Bradycardia, heart rate < 55 beats /min, high atrioventricular block without pacemaker placement. (6) Chronic pain, long-term use of opioid analgesics. (7) Severe heart, liver and kidney failure. (8) Patients with myasthenia gravis. (9) Chronic alcoholics and drug addicts. (10) Refuse to sign informed consent.

Design outcomes

Primary

Measure	Time frame
"Rass"Sedation score;	—

Secondary

Measure	Time frame
"VAS "Pain scale;	—

Countries

China

Contacts

Public ContactZhou Yuan

Neijiang City Central District People's Hospital

3134146430@qq.com+86 136 9603 7558

Outcome results

None listed

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