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Effect of remimazolam besylate on postoperative sleep quality in children

Effect of remimazolam besylate on postoperative sleep quality in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085630
Enrollment
Unknown
Registered
2024-06-14
Start date
2024-06-18
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

tonsil or adenoids hypertrophy

Interventions

Group R:infusion of remimazolam besylate
Group C:infusion of propofol

Sponsors

The Affiliated Women's and Children's Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1: 4-12 years old; 2: BMI 14-25 kg/m2; 3: ASA grade ?, II; 4: Undergoing Tonsillectomy or Adenoidectomy or both under general anaesthesia; 5: The guardian of the subject clearly understands and voluntarily participates in the study, and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1: History of neuropsychiatric diseases 2: History of cardiopulmonary diseases 3: Acute upper respiratory tract infection in the acute stage/recovery stage 4: History of any other chronic diseases 5: Pre-operative use of any sedative drugs 6: Preterm labour (gestation less than 36 weeks ) 7: Developmental delay 8: Any other condition for which remimazolam is not indicated and which, in the opinion of the investigator, makes participation in the study inappropriate (emergency surgery: hypovolemia, shock, or coma; combination of anaesthesia in addition to planned general anaesthesia; infectious cardiac disease; coagulation abnormalities, anaemia, or thrombocytopenia; hepatic or renal abnormalities; allergies or contraindications to esketamine, opioids, propofol, muscarinic medications, and their components; and patients who have been convicted of a crime or who have been subjected to a drug or drug abuse. (allergy or contraindication; have difficulty with respiratory management)

Design outcomes

Primary

MeasureTime frame
postoperative sleep quality;

Secondary

MeasureTime frame
incidence of postoperative delirium;recovery time;

Countries

China

Contacts

Public ContactHu Qiong

The Affiliated Women's and Children's Hospital of Ningbo University

49647151@qq.com+86 138 5826 2763

Outcome results

None listed

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