Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-11
SponsorMaternal and Child Health Hospital of Hubei Province
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
ASA I/II, age 3-11 years, weight 13-50 kg.
Disqualifiers
Recent upper respiratory infection.
Trial design
Design model
Parallel
Treatments tested in this trial
Ciprofol group
Other interventionIn 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
Other interventionIn 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.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: Ciprofol groupExperimental treatment 1 intervention
Group B: Propofol groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Induction 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 minutes2
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-5miutes3
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 hours4
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 hoursSecondary outcomes
1
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 hour2
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 hour3
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 1.5hours4
Dosage of anesthetic
The total amount of sedative and analgesic drugs will be recorded.
Time frame
Intraoperative period, 20 minutes - 1.5 hoursSponsors and contacts
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Source ClinicalTrials.gov