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Study on the effectiveness and safety of general anesthesia by nasal infusion of remimazolam tosylate before operation in children

Study on the effectiveness and safety of general anesthesia by nasal infusion of remimazolam tosylate before operation in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035356
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-08-30
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

Preoperative sedation under general anesthesia in children

Interventions

Group B1:Remimazolam tosylate 0.1mg·kg-1 was instilled 30 minutes before the operation (the drug was diluted to 5ml with saline and instilled in divided portions)
Group B2:Remimazolam tosylate 0.2mg·kg-1 was instilled 30 minutes before the operation (the drug was diluted to 5ml with saline and instilled in divided portions)
Group C1:30 minutes before surgery, 5ml of the same normal saline was also given, instilled through the nose in divided doses

Sponsors

Panzhihua Integrated Traditional Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 8 Years

Inclusion criteria

Inclusion criteria: 1. Subjects with strong medical compliance; 2. Subjects with normal blood routine and electrocardiogram examination; 3. The subjects who voluntarily sign the informed consent form; 4. ASA grade I-II; 5. Aged 0 to 8 years old.

Exclusion criteria

Exclusion criteria: 1. Children with mental illness; 2. Contraindications of operation in children; 3. Children with severe hepatic and renal insufficiency, severe organic heart disease, pulmonary insufficiency, malignant tumor, etc; 4. Subjects allergic to the drug in this study.

Design outcomes

Primary

MeasureTime frame
blood pressure;Mean arterial pressure;Heart rate;Blood oxygen saturation;Anesthesia induction time;Extubation time;Wake up time;

Secondary

MeasureTime frame
BIS value during tracheal intubation;BIS value when cutting the skin;Postoperative agitation rate;

Countries

China

Contacts

Public ContactQuanlin Li

Panzhihua Integrated Traditional Chinese and Western Medicine Hospital

77994534@qq.com+86 18608122098

Outcome results

None listed

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