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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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 18, 2022
Est. primary completion date December 18, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sufentanil Injection
three doses of sufentanil was intravenously given during anesthesia induction

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary adequate sufentanil dose Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects 24 hours
Secondary cut off value of Pi for valid stress assessment a validated and useful stress assessment for children during endotracheal intubation. 24 hours
Secondary 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
Secondary 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
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