Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

Not Applicable

Completed

• Conditions: Sufentanil
• Interventions: Drug: Sufentanil Injection

• Registration Number: NCT04067648
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study First Submitted: 2019-08-17
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Study Start: 2020-07-06
• Primary Completion: 2022-12-18
• Study Completion: 2022-12-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-07
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S2 group	Sufentanil Injection	Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction
S3 group	Sufentanil Injection	Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction
S1 group	Sufentanil Injection	Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
cut off value of Pi for valid stress assessment	24 hours	a validated and useful stress assessment for children during endotracheal intubation.
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
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

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China