Sufentanil
Conditions
Keywords
Sufentanil, perfusion index
Brief summary
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
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.
Interventions
three doses of sufentanil was intravenously given during anesthesia induction
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Observers and patients were double-blind. Sufentanil was assigned by a specialist. Different doses of sufentanil were allocated in the same volume according to the weight of the child.
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adequate sufentanil dose | 24 hours | Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cut off value of Pi for valid stress assessment | 24 hours | a validated and useful stress assessment for children during endotracheal intubation. |
| Narcotrend index | 24 hours | 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 |
| postoperative complications with different doses of sufentanil | 7days | Including postoperative pain and the dosage of analgesics after operation and the satisfaction of children and parents |
Countries
China
Outcome results
None listed