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The efficacy and safety of remimazolam tosylate in children undergoing enteroscopy: a single center, randomized, single blind, propofol positive control study

The efficacy and safety of remimazolam tosylate in children undergoing enteroscopy: a single center, randomized, single blind, propofol positive control study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043125
Enrollment
Unknown
Registered
2021-02-05
Start date
2021-11-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Anesthesiology

Interventions

R1:Remimazolam 0.1mg/kg
R2:Remimazolam 0.15mg/kg
R3:Remimazolam 0.2mg/kg
C:propofol 3mg/kg

Sponsors

Hunan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Aged 6-12 years; 2.ASA I-II; 3.undergong enteroscopy.

Exclusion criteria

Exclusion criteria: 1. Patients with known allergies or contraindications to benzodiazepines, flumasinil, and opioids; 2. Patients with airway management difficulties, such as chin distance 33 kg/m2); 4. The child has myasthenia gravis, intellectual retardation or neurological, mental and psychological diseases;Unable to communicate in Chinese or cooperate with investigators for other reasons.

Design outcomes

Primary

MeasureTime frame
Dose of Remazolam during Induction and maintenance of anesthesia;

Secondary

MeasureTime frame
Safety of use of Remazolam in children;

Countries

China

Contacts

Public ContactSiwei Wei

Hunan Children's Hospital

wsw769850382@qq.com+86 18588857577

Outcome results

None listed

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