Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

NCT ID: NCT04067648

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2022-12-18

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.

Conditions

Sufentanil

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

S1 group

Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction

Group Type: EXPERIMENTAL

Sufentanil Injection

Intervention Type: DRUG

three doses of sufentanil was intravenously given during anesthesia induction

S2 group

Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction

Group Type: EXPERIMENTAL

Sufentanil Injection

Intervention Type: DRUG

three doses of sufentanil was intravenously given during anesthesia induction

S3 group

Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction

Group Type: EXPERIMENTAL

Sufentanil Injection

Intervention Type: DRUG

three doses of sufentanil was intravenously given during anesthesia induction

Interventions

Sufentanil Injection

three doses of sufentanil was intravenously given during anesthesia induction

Intervention Type: DRUG

Other Intervention Names

adenotonsillectomy

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

aijun xu

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aijun XU, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

SFTA

Identifier Type: -

Identifier Source: org_study_id