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Clinical study on remimazolam besylate for induction and maintenance of anesthesia in children

Clinical study on remimazolam besylate for induction and maintenance of anesthesia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074408
Enrollment
Unknown
Registered
2023-08-07
Start date
2023-08-07
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

inguinal hernia

Interventions

preschool group:According to the anesthesia effect response of the previous patient, the next patient was randomized. When induction, LOC will be defined as a positive response
when anesthesia is maintained, BIS=60 will be defined as a positive response. If the previous patient had a positive induction or maintenance response, the next patient had a 5% probability of reducin
school age group:According to the anesthesia effect response of the previous patient, the next patient was randomized. When induction, LOC will be defined as a positive response

Sponsors

Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children who are selected to undergo "laparoscopic high ligation of inguinal hernia sac", with the operation time = 60 min 2. Age: 3-12 years old, regardless of gender 3. ASA level I to II 4. The parents or Legal guardian of the child shall sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Body mass index (BMI): BMI = 28kg/m2 or = 14 kg/m2 Weight = 10kg or = 28kg 2. Use analgesics, sedatives, antiemetics, and antipruritic drugs 24 hours before surgery 3. Children whose body temperature is higher than 38 ? within 24 hours before operation or who have symptoms of acute Upper respiratory tract infection 4. Children with a history of bronchial asthma 5. Children diagnosed with moderate to severe sleep apnea syndrome before surgery 6. Children with preoperative assessment of difficult airway or previous history of abnormal anesthesia recovery 7. Renal function damage (BUN and/or Cr>upper limit of normal value)Liver function impairment (ALT and/or AST>1.5 times the upper limit of normal value) 8. Children with a history of severe head trauma and intracranial hypertension within 6 months 9. Children with mental or neurological disorders or inability to express their wishes correctly 10. Children with a long history of taking sedative and analgesic drugs or Monoamine oxidase inhibitor 11. Those who have participated in clinical trials of other drugs within the past month 12. Children with other conditions that the researchers believe are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
anesthesia induced state of consciousness;BIS value during maintenance of anesthesia;

Secondary

MeasureTime frame
blood pressure;heart rate;blood oxygen saturation;Ramsay Sedation score;PAED agitation score;

Countries

China

Contacts

Public ContactGong Yuan

Yichang Central People's Hospital of Hubei Province

gy-yc@163.com+86 139 8674 6821

Outcome results

None listed

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