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Determination of the ED95 of a single bolus dose of remimazolam for adequate sedation in obese or nonobese children and adolescents

Determination of the ED95 of a single bolus dose of remimazolam for adequate sedation in obese or nonobese children and adolescents

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085070
Enrollment
Unknown
Registered
2024-05-30
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

obstructive sleep apnea-hypopnea syndrome

Interventions

obese group:Biased coin design method:The initial dose was 0.2 mg/kg with fixed increments of 0.05 mg/kg between dose levels.
nonobese group:Biased coin design method:The initial dose was 0.2 mg/kg with fixed increments of 0.05 mg/kg between dose levels.

Sponsors

Shanghai Children’s Hospital ,Shanghai Children’s Hospital,School of Medicine,Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 17 Years

Inclusion criteria

Inclusion criteria: (1) ASA class I-II (2) Age 3-17 years (3) Body mass index (BMI) greater than the 95th percentile (obese group) or between the 25th and 84th percentile (control group) for age and sex, respectively;

Exclusion criteria

Exclusion criteria: (1) Preoperative use of anticonvulsants, tranquilizers, or medications for attention deficit disorder; (2) Confirmed diagnosis of heart, kidney, or liver disease; (3) Chronic hypertension; (4) Hypoalbuminemia; (5) Allergy to any of the study medications.

Design outcomes

Primary

MeasureTime frame
Is remimazolam RSS = 4 three minutes after the 1-minute bolus is completed.;

Secondary

MeasureTime frame
Blood pressure (systolic, diastolic, mean) at baseline, 3min, 6min, 9min, 12min and 15min of infusion;Heart rate at baseline, 3min, 6min, 9min, 12min and 15min of infusion;SPO2 at baseline, 3min, 6min, 9min, 12min and 15min of infusion;respiratory rate at baseline, 3min, 6min, 9min, 12min and 15min of infusion;BIS at baseline, 3min, 6min, 9min, 12min and 15min of infusion;Adverse effects: including hypoxaemia, hypersensitivity, bradycardia, etc.;

Countries

China

Contacts

Public ContactJiang Yan

Department of Anesthesiology, Shanghai Children’s Hospital ,Shanghai Children’s Hospital,School of Medicine,Shanghai Jiao Tong University

xilingxi@163.com+86 138 1623 7007

Outcome results

None listed

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