Adenotonsillectomy, Ciprofol, Propofol
Conditions
Brief 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.
Interventions
OTHERCiprofol 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.
OTHERPropofol 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.
Sponsors
Maternal and Child Health Hospital of Hubei Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anesthetist satisfaction | Postoperative 30 minutes | Record the satisfaction of the anesthetist with the Ciprofol or Propofol ,defined as a score out of100.The higher score means more satisfaction |
| Mean arterial pressure (MAP) | intraoperative period,3 minutes-1 hour | MAP will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation) |
| Pediatric Anesthesia Emergence Delirium (PAED) Scale | Postoperative 1 minute-1hour | 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. |
| Adverse events | the procedure and Postoperative 24 hours | 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 |
| Heart rate (HR) | intraoperative period,3 minutes-1 hour | HR will be monitored and recorded at 4 time points, including T1 (baseline), T2 (intubation), T3 (mouth gag placement), T4 (extubation) |
| Recovery time | Postoperative 1 minutes to 1.5hours | 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. |
| Dosage of anesthetic | Intraoperative period, 20 minutes - 1.5 hours | The total amount of sedative and analgesic drugs will be recorded. |
Countries
China
Contacts
Primary ContactNa Li, MD
Outcome results
None listed