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

Effect of Three Doses of 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.

Study Overview

• Status: Completed
• Conditions: Sufentanil
• Intervention / Treatment: Drug: Sufentanil Injection

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adequate sufentanil dose	Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cut off value of Pi for valid stress assessment	a validated and useful stress assessment for children during endotracheal intubation.	24 hours
Narcotrend index	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	24 hours
postoperative complications with different doses of sufentanil	Including postoperative pain and the dosage of analgesics after operation and the satisfaction of children and parents	7days

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): December 18, 2022
• Study Completion (Actual): December 18, 2022

Study Registration Dates

• First Submitted: August 17, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Sufentanil; perfusion index
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: SFTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: According to the results of the experiment and the opinions of the children's families, it is decided whether to publish the data or not.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No