Using Ciprofol for anesthesia in children's laparoscopic surgery
Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery: a Prospective, Double-blind, Randomized Controlled, Non Inferiority Clinical Trial
This study is testing if a new anesthetic called Ciprofol can work as well as the standard one, Propofol, for children having laparoscopic surgery like hernia or appendicitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06735430 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Ciprofol as a total intravenous anesthetic in pediatric laparoscopic surgeries, comparing it to the standard anesthetic, Propofol. It is a prospective, double-blind, fully randomized controlled trial designed to determine if Ciprofol can provide similar extubation times as Propofol. The study aims to fill the gap in clinical application knowledge regarding Ciprofol in pediatric anesthesia. The primary focus is on children undergoing laparoscopic procedures for conditions such as hernia and appendicitis.
Who should consider this trial
Good fit: Ideal candidates are children scheduled for laparoscopic surgery under general anesthesia.
Not a fit: Patients with known allergies to propofol or ciprofol, or those with severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anesthetic option for children undergoing laparoscopic surgery.
How similar studies have performed: While the use of Ciprofol in pediatric anesthesia is still being explored, similar studies have shown promising results with other intravenous anesthetics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * laparoscopic surgery under general anesthesia Exclusion Criteria: * Known allergies to propofol and ciprofol, * Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders; * uncooperate with peripheral venipuncture and catheterization; * History of acute upper respiratory tract infection in the past 2 weeks; * With severe respiratory, circulation, liver and kidney insufficiency; * Body mass index (BMI) of 30 kg/m² or 15 kg/m²; * Known long-term use of sedative drugs; * ASAⅢ grade or above; * recent participation in other clinical studies.
Where this trial is running
Wuhan, Hubei
- Tongji hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: pu zhou, MD
- Email: tongjihlunli@163.com
- Phone: 02783663625
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.