Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

Sufentanil Clinical Trial

— SFTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067648
• Other study ID #: SFTA
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sufentanil

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