Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy (SFTA)

Tongji Hospital

Status: Completed

Conditions: Sufentanil

Treatments: Drug: Sufentanil Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04067648

SFTA

Details and patient eligibility

About

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 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.

Enrollment: 90 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

S1 group

Experimental group

Description:

Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction

Treatment:

Drug: Sufentanil Injection

S2 group

Experimental group

Description:

Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction

Treatment:

Drug: Sufentanil Injection

S3 group

Experimental group

Description:

Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction

Treatment:

Drug: Sufentanil Injection