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Clinical Trials/NCT04067648
NCT04067648
Completed
Not Applicable

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

Tongji Hospital1 site in 1 country90 target enrollmentJuly 6, 2020

Overview

Phase
Not Applicable
Intervention
Sufentanil Injection
Conditions
Sufentanil
Sponsor
Tongji Hospital
Enrollment
90
Locations
1
Primary Endpoint
adequate sufentanil dose
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 6, 2020
End Date
December 18, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

aijun xu

associate professor

Tongji Hospital

Eligibility Criteria

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

Arms & Interventions

S1 group

Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction

Intervention: Sufentanil Injection

S2 group

Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction

Intervention: Sufentanil Injection

S3 group

Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction

Intervention: Sufentanil Injection

Outcomes

Primary Outcomes

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

  • cut off value of Pi for valid stress assessment(24 hours)
  • Narcotrend index(24 hours)
  • postoperative complications with different doses of sufentanil(7days)

Study Sites (1)

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