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Effective dose of remazolam in inhibiting laryngeal mask implantation in children when combined with sufentanil

Effective dose of remazolam in inhibiting laryngeal mask implantation in children when combined with sufentanil

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087333
Enrollment
Unknown
Registered
2024-07-25
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Children undergoing laryngeal mask anesthesia

Interventions

Toddler Group (1-3 years):Using the modified sequential method, the initial dose of remazolam was set at 0.30mg/kg according to the pre-test results and related studies. If the larynx mask implantatio
if the larynx mask implantation reaction was negative, the dose of remazolam was decreased by 0.01 mg/kg in the next patient. For the first negative reaction, the formal test began until the alternati
Preschool Group (3-6 years):Using the modified sequential method, the initial dose of remazolam was set at 0.30mg/kg according to the pre-test results and related studies. If the larynx mask implantat
School age Group (6-12 years):Using the modified sequential method, the initial dose of remazolam was set at 0.30mg/kg according to the pre-test results and related studies. If the larynx mask implant

Sponsors

Shanghai Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Enrolled in Shanghai Children's Hospital; Aged 1 to 12 years, 2. American Society of Anesthesiologists (ASA) physical status I or II, 3. Body mass index (BMI) and weight within the normal range for the age group; 4. Elective surgery for laryngeal mask placement under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. History of surgery; 2. Known allergy to benzodiazepines; 3. Preoperative hepatic and renal dysfunction or other systemic complications; 4. Diseases of the central nervous, respiratory or circulatory systems; Mental illness; 5. Congenital heart disease; 6. Parents or patients are reluctant to sign informed consent forms.

Design outcomes

Primary

MeasureTime frame
Laryngeal mask implantation was positive;

Countries

China

Contacts

Public ContactHongyun Li

Shanghai Children's Hospital

lihyshchildren@126.com+86 152 1669 6807

Outcome results

None listed

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