Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

Study Overview
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Brief Summary
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To study the effect of different doses of sufentanil on anesthesia induction and analgesia after tonsillectomy in children. According to the different doses of sufentanil used in anesthesia induction, the children were divided into 3groups. The vital signs during anesthesia, the recovery period of anesthesia and the complications after anesthesia were compared among the groups. The anesthetic effects and safety of sufentanil at different doses were discussed, which provided theoretical basis for clinical selection of the best drug dosage.

Detailed Description
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Fifteen minutes before operation, midazolam 0.1 mg/kg was slowly intravenously injected. Five minutes later, the child entered the operating room. Pi, Narcotrend, blood pressure, ECG, SpO2 and body temperature were monitored. Penehyclidine hydrochloride 0.01 mg/kg, dexamethasone 0.1 mg/kg, propofol 3 mg/kg, sufentanil (0.3μg/kg, 0.4 μg/kg, 0.5 μg/kg) were given during anesthesia induction. cis-atracurium 0.15 mg/kg, using the required type of tube for tracheal intubation. Sevoflurane 1.0 MAC + remifentanil 0.15 ug/kg/min 50% oxygen was given during anesthesia maintenance. Effective analgesia was achieved by adjusting the dosage of remifentanil during operation. The changes of vital signs including perfusion index, Narcotrend, Bp, HR, oxygen saturation were observed before anesthesia induction, immediately after tracheal intubation, during tonsillectomy and adenoidectomy during operation, after extubation and in the recovery room. Then record the recovery time, restlessness and pain score during recovery period, postoperative pain, nausea and vomiting and other complications.

Official Title
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Effect of Three Doses of Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

Conditions
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Sufentanil

Intervention / Treatment
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* Drug: Sufentanil Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 1-12 years, ASA I-II grade; selective adenotonsillectomy BMI 18.5～23.9, Sign informed consent Exclusion Criteria: Emergency surgery; Abnormal liver and kidney function severe dehydration and malnutrition or Hb < 10g/dl; BMI <18.5 or <23.9; Children with neurological disorders

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S1 group<br>Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction | Drug: Sufentanil Injection<br>* three doses of sufentanil was intravenously given during anesthesia induction<br>* Other names: adenotonsillectomy;|
| Experimental: S2 group<br>Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction | Drug: Sufentanil Injection<br>* three doses of sufentanil was intravenously given during anesthesia induction<br>* Other names: adenotonsillectomy;|
| Experimental: S3 group<br>Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction | Drug: Sufentanil Injection<br>* three doses of sufentanil was intravenously given during anesthesia induction<br>* Other names: adenotonsillectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate sufentanil dose | Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cut off value of Pi for valid stress assessment | a validated and useful stress assessment for children during endotracheal intubation. | 24 hours | 
| Narcotrend index | explore dose and age-related hemodynamic effects of sufentanil. Next to blood pressure and heart rate and continuous Narcotrend will be monitored. Then record the correlation between perfusion index and Narcotrend | 24 hours | 
| postoperative complications with different doses of sufentanil | Including postoperative pain and the dosage of analgesics after operation and the satisfaction of children and parents | 7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sufentanil, perfusion index