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Clinical Trials in China / NCT06882980
Recruiting Not applicable

Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy

NCT06882980 · tracked via the Priya Life Science China tracker
Sponsor
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)

FacilityCityRegionStatus
Maternal and Child Health Hospital of Hubei Province Wuhan Hubei Recruiting

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Other trials for the same condition

Remimazolam Besylate in Sedation of Postcardioperative Patients Recruiting
The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial Recruiting
The Effects of Anesthetics on Brain Network Connectivity in Patients With Supratentorial Glioma Recruiting
Intranasal Dexmedetomidine-esketamine Administration and Postoperative Pain in Pediatric Patients Recruiting
Reinforcement Learned Automated Anesthesia Systems During Painless Abortion Starting soon
Official registry record

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.

View NCT06882980 on ClinicalTrials.gov ↗ ← All trials in China