Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

NCT04067648 | Completed

• 1 other identifier: SFTA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Sufentanil

Keywords

Sufentanil; perfusion index

Outcome Measures

Primary Outcomes (1)

• adequate sufentanil dose

  Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects

  24 hours

Secondary Outcomes (3)

• cut off value of Pi for valid stress assessment

  24 hours

• Narcotrend index

  24 hours

• postoperative complications with different doses of sufentanil

  7days

Study Arms (3)

S1 group

EXPERIMENTAL

Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction

Drug: Sufentanil Injection

S2 group

EXPERIMENTAL

Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction

Drug: Sufentanil Injection

S3 group

EXPERIMENTAL

Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction

Drug: Sufentanil Injection

Interventions

Sufentanil Injection DRUG

three doses of sufentanil was intravenously given during anesthesia induction

Also known as: adenotonsillectomy

S1 group; S2 group; S3 group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1-12 years,
• ASA I-II grade;
• selective adenotonsillectomy
• BMI 18.5～23.9,
• Sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aijun XU, Dr.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Observers and patients were double-blind. Sufentanil was assigned by a specialist. Different doses of sufentanil were allocated in the same volume according to the weight of the child.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 17, 2019
• First Posted: August 26, 2019
• Study Start: July 6, 2020
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)