Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

Overview

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.

Full Title of Study: “Effect of Three Doses of Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 18, 2022

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

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

Arms, Groups and Cohorts

  • Experimental: S1 group
    • Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction
  • Experimental: S2 group
    • Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction
  • Experimental: S3 group
    • Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction

Clinical Trial Outcome Measures

Primary Measures

  • adequate sufentanil dose
    • Time Frame: 24 hours
    • Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects

Secondary Measures

  • cut off value of Pi for valid stress assessment
    • Time Frame: 24 hours
    • a validated and useful stress assessment for children during endotracheal intubation.
  • Narcotrend index
    • Time Frame: 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
    • Time Frame: 7days
    • Including postoperative pain and the dosage of analgesics after operation and the satisfaction of children and parents

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tongji Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: aijun xu, associate professor – Tongji Hospital
  • Overall Official(s)
    • Aijun XU, Dr., Principal Investigator, Tongji Hospital
  • Overall Contact(s)
    • Ting Peng, Master, 86-27-83668341, 79538967@qq.com

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