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Efficacy and safety of Cyclopofol for general anesthesia in pediatric patients undergoing corrective strabismus surgery: a prospective, randomized, double-blind controlled study

Efficacy and safety of Cyclopofol for general anesthesia in pediatric patients undergoing corrective strabismus surgery: a prospective, randomized, double-blind controlled study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078654
Enrollment
Unknown
Registered
2023-12-14
Start date
2023-12-18
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Strabismus in children

Interventions

Cyclopofol group:Inducing drugs: Cyclopofol+Alfentanil+Vecuronium bromide Maintenance medication: Cyclopofol+Alfentanil
Propofol group:Inducing drugs: Propofol+Alfentanil+Vecuronium bromide Maintenance medication: Propofol+Alfentanil

Sponsors

Zhengdaguangming Eye Group-Weifang Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Meet the diagnostic criteria of strabismus; Age 3-12 years old; The American Society of Anesthesiologists (ASA) has a grade I or II rating No surgical contraindications were found in the patient's physical examination and laboratory examination. Informed consent signed by parents or legally authorized representatives;

Exclusion criteria

Exclusion criteria: Patients with systemic connective tissue disease. Patients with a history of corrective surgery for strabismus History of drug allergy and special disease before operation; Patients with partial data missing

Design outcomes

Primary

MeasureTime frame
Success rate of anesthesia;

Secondary

MeasureTime frame
Observation of injection pain;Intraoperative maintenance vital signs;Adverse reactions during postoperative recovery;BIS values before administration, LoC, after tracheal intubation, and during anesthesia maintenance period;Blood pressure, heart rate, and body movement response during laryngeal mask intubation;Extubation time;Using additional sedatives during the induction period;

Countries

China

Contacts

Public ContactXuWei

Zhengdaguangming Eye Group Weifang Eye Hospital

XU_WEI_158@163.com+86 177 6319 5334

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 12, 2026