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Clinical study on the effect of intranasal administration of rimazole on preoperative sedation in children

Clinical study on the effect of intranasal administration of rimazole on preoperative sedation in children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042317
Enrollment
Unknown
Registered
2021-01-19
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Preoperative sedation in children

Interventions

A:Remazolam besylate 0.3mg/kg
B:Remazolam besylate 0.4mg/kg
C:Remazolam besylate 0.5mg/kg
D:Midazolam 0.2 mg / kg
E:Normal saline 1ml

Sponsors

Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) The operation included adenoidectomy with (or without) tonsillectomy, laparoscopic high ligation of inguinal hernia sac, resection of body surface tumor, circumcision and penile lengthening; b) Aged 2-7 years, regardless of gender; c) ASA grade I ~ II; d) The parents or legal guardians of the children signed the informed consent.

Exclusion criteria

Exclusion criteria: a) Body mass index (BMI): BMI >= 28KG / m2 or = 28KG; b) Analgesic and sedative drugs, antiemetic drugs and anti pruritus drugs were used 24 hours before operation; c) Children whose body temperature was higher than 38 degrees C within 24 hours before operation or accompanied with symptoms of acute upper respiratory tract infection; d) Children with history of bronchial asthma.

Design outcomes

Primary

MeasureTime frame
Basal blood pressure;Basal heart rate;Basic finger pulse oxygen saturation;Blood pressure 5 minutes after administration;Heart rate 5 minutes after administration;Pulse oxygen saturation 5 minutes after administration;Sedation score 5 minutes after administration;Blood pressure 10 minutes after administration;Heart rate 10 minutes after administration;Sedation score 10 minutes after administration;Pulse oxygen saturation 10 minutes after administration;Blood pressure 15 minutes after administration;Heart rate 15 minutes after administration;Pulse oxygen saturation 15 minutes after administration;Sedation score 15 minutes after administration;

Countries

China

Contacts

Public ContactGong Yuan

Yichang Central People's Hospital

gy-yc@163.com+86 13986746821

Outcome results

None listed

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