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Safety and Efficacy of remimazolam in the treatment of anaesthetic emergence agitation in adult patients: a randomised controlled trial

Safety and Efficacy of remimazolam in the treatment of anaesthetic emergence agitation in adult patients: a randomised controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085903
Enrollment
Unknown
Registered
2024-06-20
Start date
2024-06-28
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

emergence agitation

Interventions

control:50 mg of flurbiprofen ester is administered intravenously, followed by 5 ml of normal saline.
2.5 mg Remimazolam:Flurbiprofen 50 mg is administered intravenously, followed by 2.5 mg of Remimazolam
5.0 mg Remimazolam:Flurbiprofen 50 mg is administered intravenously, followed by 5.0 mg of Remimazolam

Sponsors

Xuzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65 years; (2) 18.5 kg/m2 = BMI < 30 kg/m2; (3) ASA classification I-III; (4) Patients who recover in the recovery room after general anesthesia; (5) SAS score = 5 after extubation; (6) SPO2 = 90% can be maintained by breathing air or less than 2L/min oxygen inhalation after extubation; The patient must sign an informed consent form before the operation.

Exclusion criteria

Exclusion criteria: (1) Patients who are allergic to benzodiazepines, flumazenil, or flurbiprofen axetil, or have contraindications to these drugs; (2) Patients with dementia or any degree of cognitive impairment; (3) Patients with schizophrenia, bipolar disorder, or other psychiatric disorders; (4) Patients with difficult airways; (5) Patients with obstructed upper airway; (6) Surgery duration = 4 hours; (7) Female patients who tested positive for pregnancy screening or baseline pregnancy test and lactating women; (8) Patients who received benzodiazepine treatment for insomnia or anxiety prior to surgery; (9) Patients who tested positive for substance abuse screening or had a positive baseline alcohol test; (10) Patients with a history of drug abuse within the past 2 years or alcohol dependence; (11) Patients who participated in other drug or device studies within the past 30 days; (12) Patients who participated in any other clinical trial involving ramazolam; (13) Patients who cannot communicate effectively in spoken language.

Design outcomes

Primary

MeasureTime frame
Success rate for treatment of emergency agitation;

Countries

China

Contacts

Public ContactWang Liwei

Xuzhou Central Hospital

18952170255@163.com+86 189 5217 0255

Outcome results

None listed

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