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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
236
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.
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.
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China
RECRUITINGInduction Compliance checklist(ICC)
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
Time frame: during the time of anesthesia induction ,1 minute-10 minutes
The time to loss of consciousness during anesthesia induction
The time to loss of consciousness during anesthesia induction will be recorded after the injection of anesthetic
Time frame: after the injection of anesthetic ,1second-5miutes
sedation/consciousness (IoC1)
sedation/consciousness (IoC1) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)
Time frame: intraoperative period,10 minutes-1 hours
analgesia/pain-stress (IoC2)
analgesia/pain-stress (IoC2) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)
Time frame: intraoperative period,10 minutes-1 hours
Mean arterial pressure (MAP)
MAP will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation)
Time frame: intraoperative period,3 minutes-1 hour
Heart rate (HR)
HR will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation)
Time frame: intraoperative period,3 minutes-1 hour
Recovery time
Time to fully awake. defined as by a modified Aldrete score which will be recorded with a recovery index of 9 to 26. The higher score means more awake.
Time frame: Postoperative 1 minutes to 1.5hours
Dosage of anesthetic
The total amount of sedative and analgesic drugs will be recorded.
Time frame: Intraoperative period, 20 minutes - 1.5 hours
anesthetist satisfaction
Record the satisfaction of the anesthetist with the Ciprofol or Propofol ,defined as a score out of100.The higher score means more satisfaction
Time frame: Postoperative 30 minutes
Adverse events
The adverse events will be monitored and recorded during the operation and post-operation. AE will include:hypotension, bradycardia, respiratory depression, airway spasm, nausea, and vomiting
Time frame: the procedure and Postoperative 24 hours
Pediatric Anesthesia Emergence Delirium (PAED) Scale
The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a behavioral observation tool used to assess whether emergence delirium occurs in children after anesthesia. The total score ranges from 0 to 20.and a score of 10 or above is diagnostic of emergence delirium.A higher score indicates a greater tendency toward emergence delirium.
Time frame: Postoperative 1 minute-1hour
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