Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04067648 |
Other study ID # |
SFTA |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 6, 2020 |
Est. completion date |
December 18, 2022 |
Study information
Verified date |
January 2023 |
Source |
Tongji Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.