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Completed

NCT Number: NCT04067648

Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

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.

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Key information

Conditions

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil injection

Drug

three doses of sufentanil was intravenously given during anesthesia induction

Other names: adenotonsillectomy

Primary outcomes

  1. 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 outcomes

  1. cut off value of Pi for valid stress assessment

    Time frame: 24 hours

    a validated and useful stress assessment for children during endotracheal intubation.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Acronym: SFTA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2019
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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