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The Anesthetic Efficacy of Remimazolam in Pediatric Outpatient Strabismus Surgery

The Anesthetic Efficacy of Remimazolam in Pediatric Outpatient Strabismus Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094883
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Strabismus in Pediatric Patients

Interventions

Remimazolam group:Anesthesia was induced using propofol at 3 mg/kg and sufentanil at 3 µg/kg. Following intubation, maintenance of anesthesia was achieved with remimazolam at 1 mg/kg/h and remifentani
Propofrol:Anesthesia was induced using propofol at 3 mg/kg and sufentanil at 3 µg/kg. Following intubation, maintenance of anesthesia was achieved with propofol at 10 mg/kg/h and remifentanil at 2 µg/

Sponsors

Maternal and Child Health Hospital of Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) Children aged between 3 and 12 years who are scheduled to undergo strabismus correction surgery under general anesthesia; 2) The legal guardian of the participant must provide voluntary written informed consent for the study; 3) American Society of Anesthesiologists (ASA) physical status classification I or II; 4) No history of sedative medication use within the recent past; 5) Body Mass Index (BMI) less than 25; 6) Normal coagulation function and normal cardiovascular, hepatic, pulmonary, and renal function

Exclusion criteria

Exclusion criteria: 1) The child's family declined to provide written informed consent for participation in the trial. 2) A documented history of allergic reactions to anesthetic agents or to the active ingredients and excipients of the medications utilized. 3) Severe congenital heart disease or abnormal liver and renal function test results. 4) Children with gastroesophageal reflux disease. 5) Children exhibiting signs of altered consciousness. 6) Children with neurological conditions or a psychiatric disorder history.

Design outcomes

Primary

MeasureTime frame
boold pressure;oxygen saturation;heart rate;Regain consciousness time;Time for removal of the Laryngeal Mask;

Secondary

MeasureTime frame
The frequency of agitation during the emergence phase;Adverse Reactions Occurring Within 24 Hours Post-Surgery;Postoperative Satisfaction of the Patient's Family;

Countries

China

Contacts

Public ContactYingyao Quan

Maternal and Child Health Hospital of Hubei Province

quanyingyao266@126.com+86 186 6507 3455

Outcome results

None listed

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