Exploration of the induction dose of remimazolam in children

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076655

Enrollment

Unknown

Registered

2023-10-13

Start date

2021-05-01

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Paediatric congenital heart disease

Interventions

Control Group A:Induction of anesthesia: Remimazolam: 0.4mg/kg Sufentanil: 0.4ug/kg cis-atracurium: 0.2mg/kg

Experimental Group B:Induction of anesthesia: Remimazolam: 0.5mg/kg Sufentanil: 0.4ug/kg cis-atracurium: 0.2mg/kg

Experimental Group C:Induction of anesthesia: Remimazolam: 0.6mg/kg Sufentanil: 0.4ug/kg cis-atracurium: 0.2mg/kg

Eligibility

Sex/Gender

All

Age

2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria. Patients must meet the following inclusion criteria to be enrolled in this study. 1) Elective surgery. 2) 2 years = age = 14 years, regardless of gender. 3) mechanical ventilation with a laryngeal mask or tracheal intubation. 4) ASA class I-III. 5) 18 kg/m2<BMI<25 kg/m2

Exclusion criteria

Exclusion criteria: Exclusion criteria. Persons with any of the following were not eligible for inclusion in this study. 1) Emergency surgery 2) General intravenous anesthesia planned in addition to other forms of anesthesia such as inhalation anesthesia, intravertebral anesthesia 3) abnormal coagulation 4) Anaemia or thrombocytopenia 5) abnormal liver function 6) abnormal renal function 7) Acute heart failure 8) Patients with psychiatric disorders (mania, depression), a history of long-term use of psychotropic drugs and cognitive impairment 9) Allergy or contraindication to benzodiazepines, propofol, opioids, muscle relaxants, etc. 10) Those judged to have difficulty with respiratory management (Modified Mars Score IV) 11) have participated in a clinical trial of a drug as a subject in the last 3 months 12) Any other condition that the investigator considers inappropriate for participation in this trial

Design outcomes

Primary

Measure	Time frame
Sedation success index MOAA/S;	—

Secondary

Measure	Time frame
Remimazolam dosage;Haemodynamic indicators;Anesthesia induction time;	—

Countries

China

Contacts

Public ContactDai Ruping

The Second Xiangya Hospital of Central South University

xyeyyrupindai@csu.edu.cn+86 189 7492 4753

Outcome results

None listed

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