Purpose of this Study
If a child joins this study, they will be placed into one of two groups by chance. One group will receive a medicine called Cipepofol, and the other group will receive a medicine called Propofol. These medicines are given through a vein to help the child fall asleep before surgery. Most children will receive Cipepofol, while a smaller number will receive Propofol. All children will still receive normal anesthesia care during surgery.
Before surgery, there will be a screening visit with tests such as a physical exam, blood tests, urine tests, heart checks, and vital signs. On the day of surgery, more checks will be done. After surgery, the study team will call three times to see how the child is doing. Participation lasts for up to 29 days after surgery.
Who Can Participate?
Eligibility
Children can join this study if they are having a planned surgery that will last at least one hour and requires general anesthesia with a breathing tube. They must be generally healthy and not have had problems with anesthesia in the past. They cannot have allergies to the medicines being used in the study. They also cannot have had breathing problems during past medical procedures. The study doctor will decide if the child can join based on their health history, exam, and test results.
Age Range
3-17
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new medicine called Cipepofol to see if it is safe and works as well as a common medicine called Propofol. These medicines are used to help children and teenagers fall asleep during surgery so they do not feel pain or remember what happens. The study will include children and teenagers who are having planned surgery. Researchers want to learn if Cipepofol can safely help patients fall asleep and stay comfortable during surgery.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3b Clinical Study to Evaluate the Efficacy and safety of HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery
Principal Investigator
Benjamin
Andrew
Protocol Number
PRO00120620
NCT ID
NCT07510945
Phase
III
Enrollment Status
Pending Open to Enrollment