Actively Recruiting
Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy in Children Aged 3 to 11 Years
Led by Maternal and Child Health Hospital of Hubei Province · Updated on 2025-06-12
236
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two anesthesia drugs, Ciprofol and Propofol, in children aged 3 to 11 years undergoing adenotonsillectomy or adenoidectomy. The study evaluates how these drugs perform under two types of monitoring called IoC1 and IoC2, aiming to provide evidence about Ciprofol's safety and effectiveness in pediatric anesthesia. Children in this trial are randomly assigned to one of two groups. One group receives Ciprofol during anesthesia induction and maintenance at specified doses, while the other group receives Propofol with its own dosing schedule. Throughout surgery, vital signs and monitoring parameters IoC1 and IoC2 are continuously observed. Participants will be assessed during and after anesthesia using various measures including an Induction Compliance Checklist, time to loss of consciousness, sedation and pain-stress levels, heart rate, blood pressure, anesthetic dosage, recovery time, anesthetist satisfaction, and monitoring for adverse events. Follow-up includes observations up to 24 hours post-procedure to understand recovery and possible side effects.
CONDITIONS
Brief Title
Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA I or II classification
- Age between 3 and 11 years
- Weight between 13 and 50 kg
- Scheduled for endoscopic adenotonsillectomy or adenoidectomy
You will not qualify if you...
- Recent upper respiratory infection
- Difficult airway
- Organ dysfunction
- Developmental or psychiatric disorders
- Known drug allergies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 minutes to 1.5 hours
Participants undergo adenotonsillectomy surgery with anesthesia using either Ciprofol or Propofol. Vital signs and anesthesia depth are continuously monitored during the procedure.
1 surgery visit (in-person)
Duration - Up to 24 hours post-surgery
Participants are monitored for recovery outcomes including heart rate, blood pressure, emergence delirium, and any adverse events following surgery.
1 to 2 post-operative visits (in-person)
Trial Site Locations
Total: 1 location
1
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
N
Na Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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