A prospective randomized controlled study of Remimazolam Tosilate in programmed sedation and analgesia after neurosurgery surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078788

Enrollment

Unknown

Registered

2023-12-19

Start date

2023-12-22

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Neurosurgical Severe

Interventions

Remimazolam group :Remimazolam

Midazolam group:Midazolam

Eligibility

Sex/Gender

All

Age

19 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Age 19-80 years old; ? GCS score>5 points; Expected to require continuous analgesia and sedation, with a duration of>12 hours. ? After neurosurgical craniotomy:

Exclusion criteria

Exclusion criteria: ? History of allergic reactions to sedative drugs; ? Severe hypoxemia with oxygen saturation (SpO2)<85%; ? Severe hemodynamic instability, with MAP<60mmhg under the regulation of vasoactive drugs; Or uncontrollable arrhythmia; ? Have a history of drug abuse and abuse; ? Those who undergo craniotomy again; ? Deep coma patients, RASS score -5; ? Expected survival time<10 days. ? Failure to sign informed consent form and obtain ethical approval;

Design outcomes

Primary

Measure	Time frame
Wake up time ;Extubation time;	—

Secondary

Measure	Time frame
Mechanical ventilation time;ICU stay time;Pulmonary infection rate;mortality;	—

Countries

China

Contacts

Public ContactYuling An

Third Affiliated Hospital of Sun Yat-sen University

anyuling@mail.sysu.edu.cn+86 20 8535 2672

Outcome results

None listed

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