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SFTA: Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

Sponsor
Tongji Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04067648
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
29.4
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sufentanil Injection
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
Observers and patients were double-blind. Sufentanil was assigned by a specialist. Different doses of sufentanil were allocated in the same volume according to the weight of the child.
Primary Purpose:
Treatment
Official Title:
Effect of Three Doses of Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
Actual Study Start Date :
Jul 6, 2020
Anticipated Primary Completion Date :
Dec 18, 2022
Anticipated Study Completion Date :
Dec 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: S1 group

Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction

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

    		•
    Experimental: S2 group

    Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction

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

    		•
    Experimental: S3 group

    Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. adequate sufentanil dose [24 hours]

      Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects

    Secondary Outcome Measures

    1. cut off value of Pi for valid stress assessment [24 hours]

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

    2. Narcotrend index [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 [7days]

      Including postoperative pain and the dosage of analgesics after operation and the satisfaction of children and parents

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Wuhan Hubei China 430000

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    • Principal Investigator: Aijun XU, Dr., Tongji Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    aijun xu, associate professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT04067648
    Other Study ID Numbers:
    • SFTA
    First Posted:
    Aug 26, 2019
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by aijun xu, associate professor, Tongji Hospital
    Sufentanil
    perfusion index
    Additional relevant MeSH terms:
    Sufentanil

    Study Results

    No Results Posted as of Mar 24, 2022