Maternal and Child Health Hospital of Hubei Province
Phase
Not applicable
Started
2025-02-22
Last updated
2025-06-12
Condition(s) studied
AdenotonsillectomyPropofolCiprofol
Investigational drug(s) / intervention(s)
Ciprofol groupPropofol group
Ciprofol group: In the Ciprofol group,children were given Ciprofol 0.6-0.8 mg/kg during anesthesia induction,and ciprofol 1.2-2 mg·kg-¹·h-¹for anesthesia maintenance.Throughout the entire process, we continuously monitor vital signs and IoC1/IoC2.
Propofol group: In the Propofol group,children were given Propofol 2.5-3.5 mg/kg during anesthesia induction,and propofol 6-10 mg·kg-¹·h-¹for anesthesia maintenance.Throughout the entire process, we continuously monitor vital signs and IoC1/IoC2.
Study summary
The goal of this clinical trial is to compare the Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy Participants will be randomly allocated to two groups: Ciprofol group (Group C) and Propofol group (Group P). For those in Group C: they will be given ciprofol during anesthesia induction and maintenance .For those in Group P: they will be pgiven ciprofol during anesthesia induction and maintenanc This study evaluates ciprofol versus propofol under IoC1/IoC2 guidance in pediatric T\&A, providing evidence for ciprofol's efficacy and safety in pediatric anesthesia.
Eligibility
Sex
ALL
Min age
3 Years
Max age
11 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* ASA I/II, age 3-11 years, weight 13-50 kg.
Endoscopic T\&A or adenoidectomy.
Exclusion Criteria:
* Recent upper respiratory infection.
Difficult airway, organ dysfunction, developmental/psychiatric disorders.
Drug allergies.
Primary outcome measure(s)
Induction Compliance checklist(ICC) — during the time of anesthesia induction ,1 minute-10 minutes Induction Compliance checklist(ICC) will be recorded during the time of anesthesia induction.defined as a score out of 10.A score of 0 indicates perfect cooperation
The time to loss of consciousness during anesthesia induction — after the injection of anesthetic ,1second-5miutes The time to loss of consciousness during anesthesia induction will be recorded after the injection of anesthetic
sedation/consciousness (IoC1) — intraoperative period,10 minutes-1 hours sedation/consciousness (IoC1) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)
analgesia/pain-stress (IoC2) — intraoperative period,10 minutes-1 hours analgesia/pain-stress (IoC2) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)
Trial sites (1)
Facility
City
Region
Status
Maternal and Child Health Hospital of Hubei Province
Wuhan
Hubei
Recruiting
More Maternal and Child Health Hospital of Hubei Province trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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