Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ciprofol group, Propofol group.
- Who it may be relevant to
- Registry conditions: Adenotonsillectomy, Propofol, Ciprofol. Basic parameters: 3 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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. - Other 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.
Primary outcome measures
- Induction Compliance checklist(ICC) [Time frame: during the time of anesthesia induction ,1 minute-10 minutes]
- The time to loss of consciousness during anesthesia induction [Time frame: after the injection of anesthetic ,1second-5miutes]
- sedation/consciousness (IoC1) [Time frame: intraoperative period,10 minutes-1 hours]
- analgesia/pain-stress (IoC2) [Time frame: intraoperative period,10 minutes-1 hours]
Secondary outcome measures (7)
- Mean arterial pressure (MAP) [Time frame: intraoperative period,3 minutes-1 hour]
- Heart rate (HR) [Time frame: intraoperative period,3 minutes-1 hour]
- Recovery time [Time frame: Postoperative 1 minutes to 1.5hours]
- Dosage of anesthetic [Time frame: Intraoperative period, 20 minutes - 1.5 hours]
- anesthetist satisfaction [Time frame: Postoperative 30 minutes]
- Adverse events [Time frame: the procedure and Postoperative 24 hours]
- Pediatric Anesthesia Emergence Delirium (PAED) Scale [Time frame: Postoperative 1 minute-1hour]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
China · 1 center
- Maternal and Child Health Hospital of Hubei Province — Wuhan
Identifiers
NCT: NCT06882980 · MCHH_008