Appendicitis, Surgery, Laparoscopic Surgery, Pediatric Hernia
Conditions
Keywords
Ciprofol, Propofol, Total Intravenous Anesthesia, Children
Brief summary
a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.
Detailed 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.
Interventions
DRUGCiprofol
Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))
DRUGPropofol
Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation time | up to 1 hour | Time interval between drug withdrawal and removal of the tracheal catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aldrete Score | up to 2 hours | In the PACU, Investigators using Aldrete score scale(0- 10 points) |
| Emergence Agitation | up to 2 hours | In the PACU, Investigators assessed emergence delirium using PAED 0-20 points) |
| Postoperative Pain | 24 hours | use the FLACC pain score(0- 10 points) |
| Postoperative nausea and vomiting | 24 hours | Investigators assessed postoperative nausea and vomiting BARF scale(0-10points) |
| satisfaction degree | 24 hours | Child and/or Parent Satisfaction Survey (0-10 points) |
Countries
China
Outcome results
None listed