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Clinical Trials in China / NCT06254859
Recruiting Observational

Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery

NCT06254859 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Medical University
Phase
Observational
Started
2024-03-01
Last updated
2025-05-20

Condition(s) studied

Thyroid CancerThyroid Cancer, Papillary

Investigational drug(s) / intervention(s)

Traditional thyroid surgery.

Traditional thyroid surgery.: The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.

Study summary

This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 20-60 years old. * Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection. Exclusion Criteria: * History of past head and neck surgeries. * Pronunciation system defect and disorder history. * History of vocal cord polyps or nodules. * History of upper respiratory tract infection in the 2 weeks before surgery or postoperative infection history. * History of neurological disorders. * Abnormalities in the throat. * Preoperative damage to throat morphology or motor function. * Preoperative functional voice or language disorders, noticeable hoarseness, or difficulty in pronunciation. * Pre- and postoperative laryngoscopic examination showing vocal cord paralysis and arytenoid joint dislocation. * Neurological disorders causing abnormal throat function. * Patient unable to cooperate with VHI (Voice Handicap Index) assessment and voice spectrum examination.

Primary outcome measure(s)

  • Intraoperative electromyographic signals. — During the surgery, record R1 and V1 signals when initially identifying the recurrent laryngeal nerve or vagus nerve. After the surgery, record R2 and V2 signals upon re-identification of the recurrent laryngeal nerve or vagus nerve.
    Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 signals.
  • Voice analysis data(SPL) — Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
    Recording data(SPL) of voice tests before and after the surgery, sound pressure level in dB(A)
  • Voice analysis data(F0) — Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
    Recording data(F0) of voice tests before and after the surgery, F0 in Hz
  • Voice analysis data(Jitter) — Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
    Recording data(Jitter) of voice tests before and after the surgery, Jitter in percentage
  • Voice analysis data(Shimmer) — Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
    Recording data(Shimmer) of voice tests before and after the surgery, Shimmer in percentage

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06254859 on ClinicalTrials.gov ↗ ← All trials in China