Comparing Ciprofol and Propofol for Pediatric Adenotonsillectomy
Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
This study is testing whether a new anesthesia drug called Ciprofol works better and is safer than the standard drug Propofol for children aged 3 to 11 undergoing adenotonsillectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 3 Years to 11 Years |
| Sex | All |
| Sponsor | Maternal and Child Health Hospital of Hubei Province Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06882980 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of Ciprofol and Propofol during anesthesia for adenotonsillectomy in children aged 3 to 11 years. Participants will be randomly assigned to receive either Ciprofol or Propofol for anesthesia induction and maintenance, with monitoring under IoC1 and IoC2 guidelines. The study seeks to evaluate the efficacy and safety of Ciprofol compared to Propofol in a pediatric setting, providing valuable insights into anesthesia practices for this common surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-11 years, classified as ASA I or II, weighing between 13-50 kg, who require endoscopic adenotonsillectomy.
Not a fit: Patients with recent upper respiratory infections, difficult airways, organ dysfunction, developmental or psychiatric disorders, or drug allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of anesthesia in pediatric patients undergoing adenotonsillectomy.
How similar studies have performed: While this approach is being evaluated, similar studies comparing anesthetic agents have shown varying degrees of success, indicating potential for both improvement and further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I/II, age 3-11 years, weight 13-50 kg. Endoscopic T\&A or adenoidectomy. Exclusion Criteria: * Recent upper respiratory infection. Difficult airway, organ dysfunction, developmental/psychiatric disorders. Drug allergies.
Where this trial is running
Wuhan, Hubei
- Maternal and Child Health Hospital of Hubei Province — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Na Li, MD — Maternal and Child Health Hospital of Hubei Province
- Study coordinator: Na Li, MD
- Email: Email:lina@hbfy.com
- Phone: Telephone: Telephone:+86276349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.