Skip to content

Comparison of the efficacy of remimazolam and propofol in the treatment of restlessness in children with awakening

Comparison of the efficacy of remimazolam and propofol in the treatment of restlessness in children with awakening

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073318
Enrollment
Unknown
Registered
2023-07-06
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-10

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

Conditions

emergence agitation

Interventions

Propofol Group:When the patient has awakening agitation, intravenous propofol 1 mg/kg treatment.
Remimazolam Group:When the patient has awakening agitation, intravenous remimazolam 0.1 mg/kg treatment.

Sponsors

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Qiaokou District, Wuhan City, Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 2-12 years, ASA grade I.-II., and experienced awakening agitation after elective surgery were selected.

Exclusion criteria

Exclusion criteria: (1) Patients younger than 2 years old or older than 12 years old; (2) ASA classification =III.; (3) allergy to propofol or remazolam; (4) Preoperative pulmonary dysfunction (including pneumonia, acute lung injury, acute respiratory distress syndrome, etc.); (5) preoperative cardiac dysfunction; (6) Preoperative liver and kidney dysfunction; (7) Have a history of mental illness; (8) Patients with developmental delay and neurological disorders; (9) Patients who have participated in other studies within 90 days.

Design outcomes

Primary

MeasureTime frame
Efficient;

Secondary

MeasureTime frame
Recurrence rate of agitation after intervention;the length of stay in PACU;Incidence of respiratory depression;Incidence of laryngospasm;

Countries

CHINA

Contacts

Public ContactFang Luo

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Qiaokou District, Wuhan City, Hubei Province

luofang0909@hotmail.com+86 188 7224 6972

Outcome results

None listed

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