Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery

Tongji Hospital

Status: Completed

Conditions: Laparoscopic Surgery; Appendicitis, Surgery; Pediatric Hernia

Treatments: Drug: Ciprofol; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06735430

Tongji Hospital-20241204

Details and patient eligibility

About

a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.

Full description

Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.

Enrollment: 86 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

86 participants in 2 patient groups

Ciprofol

Experimental group

Description:

Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))

Treatment:

Drug: Ciprofol

Propofol

Other group

Description:

Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

Treatment:

Drug: Propofol