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Amnesic effect of remimazolam besylate in children:a randomized,controlled,double-blind trial

Amnesic effect of remimazolam besylate in children:a randomized,controlled,double-blind trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093394
Enrollment
Unknown
Registered
2024-12-04
Start date
2024-08-26
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None

Interventions

Propofol group:Intravenous pumping propofol (>12 mg/kg/h)
Remimazolam besylate group:Intravenous pumping remimazolam (>6 mg/kg/h)

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.According to the anesthesia risk assessment criteria developed by the American Society of Anesthesiologists (ASA), ASA I-II; 2.Age 6-12 years old; 3.Children undergoing elective surgery under general anesthesia; 4.Surgery time <=1h; 5.Voluntarily participate in this trial and sign the informed consent statement; 6.Meet the weight criteria: Boys/girls 6 years old 16.80~27.55 kg/16.10~26.30 kg Boys/girls 6.5 years old 17.53~29.57 kg/16.80~27.96 kg Boys/girls 7 years old 18.48~32.41 kg/17.58~29.89 kg Boys/girls 7.5 years old 19.43~35.45 kg/18.39~32.01 kg Boys/girls 8 years old 20.32~38.49 kg/19.20~34.23 kg Boys/girls 8.5 years old 21.18~41.49 kg/20.05~36.69 kg Boys/girls 9 years old 22.04~44.35 kg/20.93~39.41 kg Boys/girls 9.5 years old 22.95~47.24 kg/21.89~42.51 kg Boys/girls 10 years old 23.89~50.01 kg/22.98~45.97 kg Boys/girls 10.5 years old 24.96~52.93 kg/24.22~49.59 kg Boys/girls 11 years old 26.21~56.07 kg/25.74~53.33 kg Boys/girls 11.5 years old 27.59~59.40 kg/27.43~56.67 kg Boys/girls 12 years old 29.09~63.04 kg/29.33~59.64 kg

Exclusion criteria

Exclusion criteria: 1.Patients with psychiatric system disorders or cognitive dysfunction; 2.History or possibility of difficult airway conditions, such as obstructive sleep apnea syndrome; 3.Presence of neurological, cardiovascular, endocrine, hepatic and renal abnormalities; 4.People with difficulties in verbal communication and expression; 5.Subjects who used sedative drugs or received general anesthesia within 14 days prior to randomization; 6.Known allergy to the active ingredient or excipient of the drug used in this topic; 7.Voluntary participation do not agree to either sign of the informed consent statement or follow the research protocol.

Design outcomes

Primary

MeasureTime frame
Forgetting rate for set3;

Secondary

MeasureTime frame
Forgetting rate for set1;Modified observer’s assessment of alert ;Dosage of opioids during the operation ;Dosage of experimental drugs during the operation ;The time of anesthesia resuscitation ;Pulse saturation ;Blood pressure;Heart rate ;

Countries

China

Contacts

Public ContactHan Lin

The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University

nanlinhannansh@qq.com+86 158 6871 0831

Outcome results

None listed

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