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

NCT07706699 | Completed

• 1 other identifier: RLN-LCS-2024-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Disease; Recurrent Laryngeal Nerve Injury

Keywords

Recurrent laryngeal nerve; Low-current stimulation; Thyroidectomy; Intraoperative nerve identification

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 months after surgery

Secondary Outcomes (5)

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

  6 months after surgery

• Total Operative Duration in Minutes

  Intraoperative period

• Intraoperative blood loss

  Intraoperative period

• Duration of Postoperative Hospital Stay in Days

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

• Number of Participants With Stimulation-Related Adverse Events

  From initiation of intraoperative nerve stimulation through 30 days after surgery

Study Arms (3)

Control group

NO INTERVENTION

Participants underwent conventional anatomical identification and preservation of the recurrent laryngeal nerve during thyroid surgery.

3 mA group

EXPERIMENTAL

Participants underwent 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification.

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

5 mA group

EXPERIMENTAL

Participants underwent 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification.

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

Interventions

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.

3 mA group

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.

5 mA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Thyroid Diseases; Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Siqi Li

  The Second Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized to one of three parallel groups: conventional anatomical identification, 3 mA low-current stimulation-assisted identification, or 5 mA low-current stimulation-assisted identification.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)