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NCT Number: NCT07706699

Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery

This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery.

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Key information

Conditions

Thyroid Disease Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Endocrine System Diseases Laryngeal Diseases Laryngeal Nerve Injuries Nervous System Diseases Otorhinolaryngologic Diseases Recurrent Laryngeal Nerve Injuries Recurrent Laryngeal Nerve Injury Respiratory Tract Diseases Thyroid Diseases Trauma, Nervous System Vagus Nerve Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

About this study

A total of 150 patients undergoing thyroid surgery at the Second Affiliated Hospital of Kunming Medical University were randomly allocated in a 1:1:1 ratio to conventional anatomical identification, 3 mA low-current stimulation, or 5 mA low-current stimulation. All participants underwent preoperative and postoperative electronic laryngoscopy. The primary outcome was temporary recurrent laryngeal nerve injury. Secondary outcomes included permanent recurrent laryngeal nerve injury, operative duration, intraoperative blood loss, postoperative hospital stay, and stimulation-related adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for thyroid surgery.
  • No history of prior thyroid or neck surgery.
  • Normal bilateral vocal cord mobility on preoperative electronic laryngoscopy.
  • Written informed consent provided before enrollment.

Exclusion criteria

  • Preoperative recurrent laryngeal nerve dysfunction.
  • Previous neck surgery.
  • Incomplete clinical data.
  • Severe comorbidities precluding standardized perioperative assessment.

Treatment and study plan

3 mA low-current stimulation-assisted recurrent laryngeal nerve identification

Procedure

Low-current stimulation at 3 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.

5 mA low-current stimulation-assisted recurrent laryngeal nerve identification

Procedure

Low-current stimulation at 5 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.

Primary outcomes

  1. Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy

    Time frame: 6 months after surgery

    Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.

Secondary outcomes

  1. Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy

    Time frame: 6 months after surgery

    Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.

  2. Total Operative Duration in Minutes

    Time frame: Intraoperative period

    Total operative duration will be measured in minutes from the initial skin incision to completion of skin closure.

  3. Intraoperative blood loss

    Time frame: Intraoperative period

    Estimated intraoperative blood loss measured in milliliters.

  4. Duration of Postoperative Hospital Stay in Days

    Time frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery

    Postoperative hospital stay will be calculated as the number of calendar days from the date of surgery to the date of hospital discharge.

  5. Number of Participants With Stimulation-Related Adverse Events

    Time frame: From initiation of intraoperative nerve stimulation through 30 days after surgery

    The number of participants experiencing at least one stimulation-related adverse event will be reported. Stimulation-related adverse events include suspected thermal injury, arrhythmia, hemodynamic instability, muscle burn, overstimulation, or suspected false-negative nerve localization, as documented in the intraoperative and postoperative medical records.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

Clinical Utility of Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery: A Single-Center Prospective Randomized Interventional Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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