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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol group | Experimental | Ciprofol group patients will be given ciprofol during anesthesia induction and maintenance |
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| Propofol group | Active Comparator | Propofol group patients will be given propofol during anesthesia induction and maintenance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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) | 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) | intraoperative period,10 minutes-1 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | intraoperative period,3 minutes-1 hour |
| Heart rate (HR) |
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Inclusion Criteria:
Endoscopic T&A or adenoidectomy.
Exclusion Criteria:
Difficult airway, organ dysfunction, developmental/psychiatric disorders.
Drug allergies.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na Li, MD | Contact | Telephone: Telephone:+86276349 | Email:lina@hbfy.com |
| Name | Affiliation | Role |
|---|---|---|
| Na Li, MD | Maternal and Child Health Hospital of Hubei Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Hospital of Hubei Province | Recruiting | Wuhan | Hubei | 430000 | China |
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| Propofol group | Other | 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. |
|
HR will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation)
| 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. | Postoperative 1 minutes to 1.5hours |
| Dosage of anesthetic | The total amount of sedative and analgesic drugs will be recorded. | 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 | 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 | 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. | Postoperative 1 minute-1hour |